Post Dural Puncture Headache: The End of the Beginning
Joseph Eldor, MD
"I could never say in the morning, 'I have a headache and cannot do thus and so.' Headache or no headache, thus and so had to be done." (Eleanor Roosevelt)
"Now this is not the end. It is not even the beginning of the end, but it is, perhaps, the end of the beginning" (Winston Churchill)
1. Tissue Coring
2. Outpatient spinal anesthesia
3. Pediatric spinal anesthesia
4. Obstetric spinal anesthesia
5. Continuous spinal anesthesia
6. Young adult spinal anesthesia
7. Spinal anesthesia under the microscope
8. Combined spinal-epidural anesthesia
9. Cerebrospinal fluid
10. Back pain
13. Needle gauge and tip
Baris et al (1) looked whether tissue coring occurs with 22-G hollow needle and 22-G caudal block needle during caudal injection in children, as well as evaluating the nature of the coring material if it did occur. Seventy children were randomly allocated to two groups and caudal block was performed with either 22-G hollow (group I) or 22-G caudal block (group II) needle under general anesthesia. The needles and guides were washed with 0.5 ml of 70% ethanol in a sterile tube and were evaluated by a pathologist blinded to the type of needle used, for the type and number of cells. Nucleated cells, which have no mitotic activity, were present in 8.5% in each study group and bloody material was present in 8.5 and 2.8%, in group I and II, respectively. Non-nucleated epidermal cells were detected in 94.2 and 97.1% of the patients in group I and II, respectively. However, cells with mitotic activity from the stratum basale were not detected in any slides. The incidence of transporting nucleated epidermal cells with no mitotic activity from stratum spinosum during puncture for caudal block is low and no differences exist between different types of needle used. However, it may also suggest that transporting nucleated cells with mitotic activity from the stratum basale may be possible during caudal puncture.
Tissue cores, implanted into the subarachnoid space during subarachnoid injections, can develop into intraspinal lumbar epidermoid tumors. The availability of smaller needles has made spinal anesthesia more popular. Campbell et al. (2) in a prospective, randomized, blinded study examined whether tissue coring occurs with two of the currently used 25-gauge spinal needles. Fifteen 25-gauge Quincke and seventeen 25-gauge Whitacre spinal needles, in which cerebrospinal fluid (CSF) was not identified and the local anesthetic solution not injected, were obtained from adult male patients undergoing spinal anesthesia. The needles were then evaluated by a pathologist following randomization with similar sterile, unused spinal needles. Twenty additional needles, ten of each type, in which CSF was identified and through which local anesthetic was injected, were also randomized with similar sterile, unused spinal needles and examined. Tissue cores were identified in 12 of the 15 Quincke and 7 of the 17 Whitacre spinal needles in which CSF was not identified (P < .05). Of the 20 needles in which CSF was identified and local anesthetic injected, no tissue cores were identified in the 10 Whitacre needles and only one small tissue core was identified in the 10 Quincke needles. All the tissue cores were identified as fat tissue. The 25-gauge Quincke and 25-gauge Whitacre spinal needles currently used in anesthesia can produce tissue coring.
Outpatient spinal anesthesia
Seven hundred thirty ambulatory surgery patients, randomly assigned to receive spinal anesthesia with a 26- or 27-G needle, were studied for the incidence of post-dural puncture headache (PDPH), postoperative back pain, and patient acceptance (3). The incidence of PDPH following the use of 26- and 27-G needles was 9.6% and 1.5%, respectively (P less than 0.05). The incidence of PDPH was 5.7% among men and 13.4% among women following the use of 26-G needles (P less than 0.05), whereas no difference between men and women was noted after the use of 27-G needles. Of the patients who were 40 yr of age or younger, the overall incidence of PDPH was 11.9%, with a 7.5% incidence among men and a 16.4% among women following the use of 26-G needles (P less than 0.05) and a 1.8% incidence of PDPH following the use of 27-G needles, with no statistical difference between genders. Postoperative back pain was experienced in 18.3% of the patients in the 26-G group and 20.2% in the 27-G group (difference not significant). Favorable acceptance of spinal anesthesia was reported in 89.4% of patients in the 26-G group and 98.2% in the 27-G group (P less than 0.01). Results from this study demonstrate that, in patients who received spinal anesthesia for ambulatory surgery, the use of 27-G needles resulted in a significantly lower incidence of PDPH and greater patient acceptance compared with the use of 26-G needles. The incidence of postoperative back pain was not significantly different between the two groups.
The records of 160 day-care surgical patients who received intrathecal anaesthesia were reviewed (4). No major complications were recorded. The incidence of postspinal headache after puncture with a 25-gauge spinal needle was nearly four times more frequent compared to a 26-gauge needle. The occurrence of postspinal headache in patients over the age of 45 years was significantly less frequent (p less than 0.05) than in younger patients. Intrathecal anaesthesia was acceptable to 91% of outpatients in this group.
The incidence of headache after spinal anaesthesia has varied greatly between studies. Santanen et al. (5) compared the incidence of postoperative headache in general and postdural puncture headache (PDPH) when using 27-gauge (G) (outer diameter 0.41 mm) Quincke and Whitacre spinal needles in ambulatory surgery performed under spinal anesthesia. In a prospective, randomized study, 676 ASA physical status I-II day-case outpatients were given a spinal anesthetic through either a 27-G (0.41 mm) Quincke or a 27-G (0.41 mm) Whitacre spinal needle. The incidence of any type of postoperative headache was assessed and the type of headache defined using a standardized questionnaire including PDPH criteria. The severity of the headache was defined using a 100-mm visual analogue scale. For the final analysis, 529 patients were available (259 patients in the Quincke group and 270 patients in the Whitacre group). The overall incidence of postoperative headache was 20.0%, but the incidence of true PDPH was very low (1.51%). The incidence of PDPH in the Quincke group was 2.70%, while in the Whitacre group it was only 0.37% (P < 0.05). The overall incidence of non-dural puncture headache was 18.5% and did not differ between the study groups. True PDPH seldom occurs when a 27-G (0.41 mm) spinal needle is used, although postoperatively a non-specific headache is common. Using the 27-G (0.41 mm) Whitacre spinal needle further reduced the incidence of PDPH.
Two large studies reported a very low rate (0.5-1.8%) of postdural puncture headache (PDPH) with the use of 27-G spinal needles. Despond et al. (6) suspected that it might be higher in young ambulatory patients. The purpose of their study was to establish the rate prospectively in such a patient population using two types of needles. Two hundred male and female, outpatients, 18-45 yr, undergoing knee arthroscopy under spinal anaesthesia were randomly assigned to receive spinal anaesthesia with hyperbaric lidocaine 5% using either a Quincke or a Whitacre 27-G needle. Twenty patients choosing general anaesthesia formed a comparative group. Using a previously validated questionnaire, the incidence and nature of PDPH were evaluated by telephone three to five days after surgery by an anesthetist unaware of the anesthetic technique used. Once all data were collected, an anesthetist not involved in the study determined in a blinded fashion which headaches were likely to be PDPH. Grading and classification of headaches were based on several criteria: postural nature, duration, intensity and confinement to bed. The overall incidence of PDPH in both spinal groups was 9.3%. The incidence in women, 20.4%, was higher than in men, 5.5%, (P < 0.05). Only one patient required a blood patch. Both types of needle were comparable with respect to the incidence, severity and duration of PDPH, number of dural punctures and failed spinal blocks. The rate of PDPH was higher than in large published studies with 27-G Quincke and Whitacre needles and greater in women than in men.
Spinal anesthesia in day-care surgery is still controversial because of the possibility of postdural puncture headache (PDPH). The use of the Sprotte needle with a conical tip that spreads the dural fibers may reduce the incidence of PDPH. Pittoni et al. (7) compared the 22-gauge and 25-gauge Sprotte needles with respect to PDPH and postoperative complaints in out-patients undergoing arthroscopy. The rate of spinal anesthesia failure and the feasibility of unilateral spinal anesthesia when using a low dose of anesthesia was also verified. For this randomized, prospective study, 234 patients undergoing elective arthroscopy were chosen. Patients were allocated randomly to have spinal anesthesia with either a 22-gauge or 25-gauge Sprotte needle. Dural puncture was performed with the patient in a lateral flexed decubitus position. After the injection of anesthetic solution (0.5-1.2 mL of 1% bupivacaine in 8% glucose) patients remained in the lateral decubitus position for 30 min. The time to regression of analgesia, time of micturition, and all postoperative complaints were recorded. The most frequent side effect was backache (10.2%) with a more frequent incidence in the group using the 22-gauge needle (14.5% and 5.9%, respectively). PDPH was recorded in only one patient (0.8%) in the group using the 22-gauge needle. The failure rate was 0.8%. Unilateral anesthesia was achieved in 88% of 213 patients.
Jost et al. (8) evaluated the incidence of side-effects in patients bearing a high risk of post dural puncture headache (PDPH) when a spinal anesthesia was performed. This included outpatients, patients for cesarean sections and patients younger than 40 years who were mobilized as soon as the surgeon agreed. Spinal anesthesia for cesarean section was applied with a G27 Whitacre needle with the patient in the right lateral decubitus position. Hyperbaric Bupivacaine 2-2.2 ml (10-12 mg) was injected when spontaneous flow of spinal fluid occurred through the needle. The preparations for the surgery then started immediately with the patient in a left lateral position. Intravenous Ephedrine (10-20 mg) was given simultaneously. All the other spinal anesthesias were performed in a similar manner with the patient lying on the side of the scheduled surgery. For outpatients Articaine was used instead of Bupivacaine. In those outpatients older than 60 years a 26 G Quincke needle was used for spinal anesthesia. All in-hospital patients were visited once or more during the first 48 hours and asked about side-effects e.g. PDPH. Outpatients older than 60 years were interviewed by a telephone call on the third day after surgery. The younger ones were asked to send back a questionnaire free of charge. None of the 206 patients (mean age 30.7 years) who underwent cesarean section suffered from headache. Lower back pain was seldom  and moderate. They all had the bladder drained as a routine measure of the obstetrician. 547 of 600 in hospital patients were mobilized as soon as the block disappeared. 11 complained of headache. 2 (1.8%) females needed oral non-opioid analgesics, one 17-year-old woman an epidural blood patch (0.17%). 150 of the outpatients younger than 60 years sent back the questionnaire spontaneously. 75 had to be reminded by a telephone call. 10 of these 225 had PDPH but only 2 females needed oral non-opioids for one day. One 34-year-old woman needed conservative treatment with oral fluid intake more than 3 liters a day, analgesics and bed rest. None of the outpatients older than 60 years complained of headache. Two suffered from vomiting on the way home. Three males had disturbed bladder function, but did not need catheterization. The use of a thin pencil point needle (Whitacre G27) enables the application of a spinal anesthesia to young people with a low risk of moderate PDPH. Pregnancy is not a contraindication. Early mobilization does not increase the risk of PDPH even in young patients nor it is the case in outpatients. In outpatients older than 60 years a G26 Quinke needle, which is easier to handle and cheaper, is suitable for spinal anesthesia without a risk of PDPH. Better post-operative vigilance may be a further benefit of the method. Young people especially appreciated the option to pursue their own video-endoscopic surgery. In a comparable group where an epidural was performed there were more side-effects.
In a prospective study of 51 young male outpatients given spinal anesthesia through a 25-gauge needle, Flaatten and Raeder (9) found a 37.2% incidence of postdural puncture headache. In addition, 54.9% complained of backache after surgery. Occurrence of headache significantly prolonged the sick-leave from work. General anesthesia would be preferred by 31.4% of patients for a similar procedure in the future. These patients had a higher incidence of postoperative backache and pain during lumbar puncture. It was concluded that spinal anesthesia is not a satisfactory technique for outpatient procedures in young men.
However, there has been a renewed interest in spinal anesthesia in recent years but its use for ambulatory surgery patients has not been as well accepted as its use for inpatients because of the high incidence of postdural puncture headache (PDPH) and uncertain patient recovery time before hospital discharge. Studies indicate that the incidence of PDPH can be lowered to an acceptable level by applying improved techniques such as the use of a 27-g spinal needle or a needle with a tip designed like a pencil point, such as a Whitacre (Becton-Dickinson, Rutherford, NJ) or Sprotte (Pajunk, Geisingen, Germany) needle. Also, by using xylocaine or bupivacaine, which are short- or intermediate-acting local anesthetics, rather than tetracaine, a long-acting anesthetic, patients can be safely discharged from the hospital within 4 to 6 hours from the induction of anesthesia. These improved techniques have allowed spinal anesthesia to be a valid, even desirable, option for selected patients undergoing ambulatory surgery. When considering spinal anesthesia for ambulatory surgery patients, it is important that the postanesthesia care staff be knowledgeable, because nursing care is one of the three integral parts of total patient care that makes ambulatory surgery successful. The other two components are surgery and anesthesia management (10).
Pediatric spinal anesthesia
In the last decade the use of spinal anaesthesia (SA) in paediatric anaesthesia has increased. In adults, pencil point spinal needles are supposed to be less traumatic and hence to be superior compared with cutting point needles in respect of postpuncture complaints. In children, the use of spinal needles with a special tip design have not been compared. Kokki et al. (11) studied the clinical utility and postpuncture characteristics of four newly designed spinal needles in paediatric surgery. In this open-randomised, parallel groups, prospective study they compared the puncture quality, success rate and postpuncture characteristics in 200 children aged 2 to 128 months. Two cutting point needles; a 50-mm-long 25G Quincke and a 25-mm-long 26G Atraucan were compared with two pencil point needles; a 37-mm-long 27G Whitacre and a 35-mm-long 24G Sprotte. The children were premedicated with oral diazepam and those anxious or uncomfortable after premedication were sedated with i.v. thiopentone or propofol. Bupivacaine 5 mg ml-1 0.3-0.5 mg kg-1 was used for the SA. The spinal puncture was successful with one or two skin punctures in 96% of children. The cutting point needles were easier to insert through the skin and ligaments (P = 0.001) but the pencil point needles gave a better (P = 0.001) indication of the dural passage. The success rate of the SA was 91% without differences between the needles. Five patients were given general anaesthesia and 13 children a single dose of i.v. fentanyl/sedative. The spinal block was completed in less than 3 min in 96% of the cases without differences between the needles. Seventeen children developed a headache, 10 of which were classified as a postdural puncture headache (PDPH), 3 with the Sprotte, 3 with the Quincke and 4 with the Atraucan needles. The youngest child developing PDPH was a 12-month-old boy. Eight of the PDPH were mild and 2 moderate. Ten children developed a low back pain, 2-3 in each study group. Three children in the pencil point groups developed signs of transient radicular irritation. SA using bupivacaine and the study needles produced smooth and safe anaesthesia for paediatric surgery with a high success rate. PDPH after SA is as common in children (5%) as in adults although most often mild and short lasting. SA using bupivacaine can cause transient radicular irritation.
Kokki et al. (12) studied 215 children aged 1 to 18 years. A 25-gauge needle was used in children up to 7 years (n=96) and a 27-gauge needle in older children (n=119). During lumbar puncture with either a cutting-point (n=109) or a pencil-point (n=106) spinal needle, they recorded puncture characteristics and the success of cerebrospinal fluid (CSF) aspiration. Hyperbaric bupivacaine 5 mg ml(-1) at a dose of 0.3-0.4 mg kg(-1) was used for the spinal anaesthesia. The incidence of postdural puncture complications was recorded from diaries completed by the children and parents one week after the lumbar puncture. The success rate of the spinal anaesthesia was 97% without difference between the needles. The success rate was higher when the aspiration of CSF was easy compared to if it was difficult (98% vs. 88%, P=0.02). Two hundred and seven diaries were returned (97%). Twenty-four children developed a headache, 8 of which were classified as a postdural puncture headache (PDPH), 6 with the cutting-point needle and 2 with the pencil-point needle (n.s.). Nine children developed signs of transient radicular irritation with no difference between the needles. Both types of spinal needles can be used in children, and a free aspiration of CSF results in a high success rate of the spinal block. Postpuncture complications are as common in children as in adults.
Many reports have shown a low incidence of postdural puncture headache (PDPH) and other complaints in young children. Kokki et al. (13) in an open-randomized, prospective, parallel group compared the use of a cutting point spinal needle (22-G Quincke) with a pencil point spinal needle (22-G Whitacre) in children. They studied the puncture characteristics, success rate and incidence of postpuncture complaints in 57 children, aged 8 months to 15 years, following 98 lumbar punctures (LP). The patient/parents completed a diary at 3 and 7 days after LP. The response rate was 97%. The incidence of PDPH was similar, 15% in the Quincke group and 9% in the Whitacre group (P=0.42). The risk of developing a PDPH was not dependent on the age (r < 0.00, P=0.67). Eight of the 11 PDPHs developed in children younger than 10 years, the youngest being 23-months-old.
Kokki and Hendolin (14) compared a 25 G with a 29 G Quincke needle in paediatric day case surgery. Sixty healthy children aged 1 year to 13 years were randomly allocated to have spinal anaesthesia with either 25 G or 29 G Quincke needle without an introducer needle. There was a failure rate of 10% with the 29 G spinal needle compared with 0% with the 25 G needle. The time needed to perform dural puncture was shorter using 25 G than 29 G needle, 22 (+/- 31)(SD) vs 59 (+/- 63) s. The time taken for cerebrospinal fluid to appear at the needle hub was also longer, 4 (+/- 3) vs 8 (+/- 5) s. The number of puncture attempts was similar, 1.2 (+/- 0.6) vs 1.4 (+/- 0.8), with 25 G and 29 G needle. Low back pain, 5 vs1, and nonpositional headache, 2 vs 4, after 25 G and 29 G needles, respectively, were the most frequent postoperative complaints. Mild postdural puncture headache occurred in one eight year old male patient in the 25 G group. Lumbar puncture without introducer needle was possible with both needles. The puncture characteristics favoured the 25 G needle. A shorter needle could partly alleviate the difficulties with the 29 G needle.
Obstetric spinal anesthesia
Imarengiaye and Edomwonyi (15) compared the insertion characteristics and rate of complications between 25-gauge Quincke and 24-gauge Gertie Marx needles in a prospective, randomized study in the University of Benin Teaching Hospital; a university-affiliated tertiary centre. Parturients (ASA 1 and 2) scheduled for elective caesarean section. They were randomly assigned to receive spinal anaesthesia with either 25-gauge Quincke needle or 24-gauge Gertie Marx needle. The patients with abnormal spaces, coagulopathy, infection, pre-eclampsia/eclampsia or obesity were excluded. Sixty women were studied. The 24-gauge Gertie Marx needle resulted in more successful location of the spinal space on the second attempt (P<0.05). Non-postdural puncture headache was seen in 43% of the study population. PDPH was seen in 10% of the Quincke group and none in the Gertie Marx group. There was no difference in the incidence of backache in both groups. The ease of insertion and low incidence of PDPH with the Gertie Marx needle may encourage trainee anaesthetists to use this needle for caesarean section.
In Taiwan, there was only a retrospective study about the post-dural puncture headache (PDPH) resulting from spinal anesthesia for cesarean section (C/S), but it did not mention the relationship between the incidence of PDPH and the number of dural punctures, as well as between the gauge of spinal needle. Therefore, Hwang et al. (16) designed a prospective study to investigate if the spinal needles of smaller gauges could decrease the incidence of PDPH in anesthesia for C/S. From Jan. 1990 to June 1991 they prospectively observed 2,385 consecutive cases of spinal anesthesia for various types of surgical procedures, of which 584 were C/S. The spinal needles used were of gauges 24, 25 and 26. In practice, needles of these gauges were randomly applied. The PDPH was observed until its disappearance, and nonexistence of PDPH was also followed for at least one week. All of the data were analyzed using the Fisher exact test. The overall incidence of PDPH was 1.18%. The incidence of PDPH in C/S females was 3.08%, which was significantly higher than that in non-obstetric females (0.37%). Although the incidence in all females (1.31%) was significantly higher than that in males (0.71%), the incidence in non-obstetric females (0.37%) did not differ significantly compared with males. The incidence of PDPH relevant to the gauges of spinal needle used was not statistically different in C/S females. It appears that the incidence of PDPH does not differ between Taiwanese and Westerners. Pregnancy may be the key factor contributing to higher incidence of PDPH. The 26-gauge spinal needle may lower the incidence of PDPH to a greatest extent in C/S patients, although in comparison with 24- and 25-gauge needles the difference is not statistically significant.
A retrospective review of obstetric anesthesia charts was performed for all parturients receiving regional anesthesia over a 22-month period (17). The incidence of headache, post dural puncture headache (PDPH) and various other complications of regional anesthesia that had been prospectively assessed were noted, as was the anesthetic technique used (epidural or combined spinal epidural (CSE)). PDPH was rare (0.44%) and occurred with similar frequency in those managed with either epidural or CSE anesthesia or analgesia. The pencil-point spinal needle gauge (27 or 29) did not influence the incidence of PDPH. Following a CSE technique, the epidural catheter more reliably produced effective analgesia/anesthesia as compared with a standard epidural technique (1.49% versus 3.18% incidence of replaced catheters respectively). Based on the results of this retrospective review, CSE is acceptable with respect to the occurrence of PDPH and that it is possible it is advantageous in relation to the correct placement of the epidural catheter.
Postoperative headache and back pain has limited the use of intrathecal anesthesia in younger patients (15-45 years). Brattebo et al. (18) studied postoperative complaints among 133 healthy young patients (mean age 30.0 years, 47% females) who received spinal anesthesia with a 27G needle. Postoperatively, 5 patients (4%) complained of postdural puncture headache (PDPH), 18 (14%) reported nonspecific headache, while 27 (20%) suffered from back pain. PDPH was not related to sex, age, day-care surgery, number of puncture attempts, or obstetric procedures. Back pain was significantly more common among females, and among in-patients. One hundred and sixteen patients (87%) would accept spinal anesthesia if they were to undergo the same surgical procedure again. Compared to other studies, it was found that the incidence of post anesthetic complaints to be acceptable, also among day-care patients. The PDPH seemed to be lightly incapacitating, and only one patient required blood patching.
Parturients have the greatest risk of postdural puncture headache. use of a pencil-point needle, such as the 25 gauge Whitacre, has been associated with a lower incidence of PDPH. Douglas et al. (19) made an observational study of 1009 obstetrical patients to assess possible factors related to the incidence of PDPH and other complications associated with spinal anesthesia using the 25 gauge Whitacre needle. The independent variables included procedure, maternal position at insertion, ease of insertion, intraoperative i.v. analgesia supplementation, use of intrathecal narcotics, parity and type of local anesthetic. Patients were followed daily during their hospitalization and questioned specifically about the presence of headache, its nature, onset and treatment. Two hundred and twenty-nine patients developed a headache postperatively but only 25 had postdural puncture headaches (overall incidence 2.5%). The PDPH typically presented on day 2 (median), range 1-4). Six patients (0.59%) required epidural blood patch. There were eight (0.8%) failed spinals which were converted to general anesthesia. None of the factors evaluated were significant in predicting the occurrence of PDPH.
Sears et al. (20) compared the frequency of postdural puncture headache (PDPH) in obstetric patients when using the 24-gauge or the larger 22-gauge Sprotte needle in a prospective, randomized study in four hospitals in 375 ASA physical status I and II cesarean section and postpartum tubal ligation patients. Obstetric patients were randomly assigned to receive spinal anesthesia via a midline dural puncture using the 24-gauge or the 22-gauge Sprotte needle. The rate of PDPH was determined by a postoperative visit by the anesthesiologist as well as questioning patients by telephone 1 week or more after discharge. In the 24-gauge Sprotte needle group (n = 186), 2 mild and 1 moderate PDPHs were reported, for an overall rate of 1.61%. In the 22-gauge Sprotte needle group (n = 189), 2 mild and 1 moderate PDPHs were reported, for an overall rate of 1.59%. All headaches except 1 resolved within 72 hours with conservative treatment. One patient from the 22-gauge Sprotte needle group required an epidural blood patch. There were no failed blocks in either group. These results suggest that the 22-gauge Sprotte needle, when compared with the smaller 24-gauge Sprotte needle, can be used in obstetric patients without increasing the frequency of PDPH.
Postdural puncture headache (PDPH) is an iatrogenic complication of neuraxial blockade. Choi et al. (21) systematically reviewed the literature on parturients to determine the frequency, onset, and duration of PDPH. Citations on PDPH in the obstetrical population were identified by computerized searches, citation review, and hand searches of abstracts and conference proceedings. Citations were included if they contained extractable data on frequency, onset, or duration of PDPH. Using meta-analysis, they calculated pooled estimates of the frequency of accidental dural puncture for epidural needles and pooled estimates of the frequencies of PDPH for epidural and spinal needles. Parturients have approximately a 1.5% [95% confidence interval (CI) 1.5% to 1.5%) risk of accidental dural puncture with epidural insertion. Of these, approximately half (52.1%; 95% CI, 51.4% to 52.8%) will result in PDPH. The risk of PDPH from spinal needles diminishes with small diameter, atraumatic needles, but is still appreciable (Whitacre 27-gauge needle 1.7%; 95% CI, 1.6% to 1.8%). PDPH occurs as early as one day and as late as seven days after dural puncture and lasts 12 hr to seven days.
Echevarria et al. (22) compared the incidence of postdural puncture headache after subarachnoid anesthesia with a 24G Sprotte needle among full-term obstetric patients as compared to non-obstetric patients. A total of 200 patients were studied prospectively, divided into 2 groups. Group 1 (n = 100) patients were delivered by cesarean section and group 2 (n = 100) patients underwent infraumbilical or traumatological surgery. All were ASA I-II and under 40 years of age. Hydration was accomplished with lactated Ringer's solution 400-1,000 ml before mid-line puncture. The anesthetic used in both groups was isobaric bupivacaine 0.5% with a vasoconstrictor. The incidence of arterial hypotension and accompanying symptoms was recorded; perioperative administration of vasoactive amines and anticholinergics and liquids administered was measured. Twenty-four to 48 hours later the patients were asked when they started walking and if postdural puncture headache was experienced. Group 1 received smaller doses of bupivacaine (p < 0.05) and the incidence of arterial hypotension was greater (p < 0.01) and required increased administration of amines (p < 0.01) and perioperative fluid therapy (p < 0.001). No difference was found between the two groups either for time of start of ambulation or for incidence of headache, which was 1% in both groups.
Hwang et al. (23) prospectively observed 94 spinal anesthesias for cesarean section performed during the period from May 1993 to July 1995. The 25-gauge Whitacre needles were used. In practice the insertion of needle was made through median line approach and the puncture was considered eligible only in one attempt. The PDPH was observed until its disappearance, and one without PDPH had also been observed for at least one week for likelihood of delayed occurrence. The data were compared with those of a previous study regarding the use of 25- and 26-gauge Quincke needles in obstetric patients. All of the data were analyzed using the Fisher exact test. The incidence of PDPH was 1.06%. In comparison there was no significant difference from that of 25- and 26-gauge Quincke needles (3.65% and 2.06%, respective). Only one case suffered from PDPH in the Whitacre group. It was mild and relieved with bed rest and hydration. Although the difference was not statistically significant, the 25-gauge Whitacre spinal needle caused a lower incidence and less severity of PDPH than the 25- and 26-gauge Quincke needles did.
Vallejo et al. (24) made a prospective, blinded, randomized study to compare the incidence of postdural puncture headache (PDPH) and the epidural blood patch (EBP) rate for five spinal needles when used in obstetric patients. One thousand two women undergoing elective cesarean delivery under spinal anesthesia were recruited. They used two cutting needles: 26-gauge Atraucan and 25-gauge Quincke, and three pencil-point needles: 24-gauge Gertie Marx (GM), 24-gauge Sprotte, and 25-gauge Whitacre. The needle for each weekday was chosen randomly. Cutting needles were inserted parallel to the dural fibers. The incidences of PDPH were, respectively, 5%, 8.7%, 4%, 2.8%, and 3.1% for Atraucan, Quincke, GM, Sprotte, and Whitacre needles (P = 0.04, chi(2) analysis), and the corresponding EBP rates in those with PDPH were 55%, 66%, 12.5%, 0%, and 0% (P = 0.000). The Quincke needle had a more frequent PDPH rate than the Sprotte or the Whitacre needle (P = 0.02) and a more frequent EBP rate than the GM, Sprotte, or the Whitacre needle (P = 0.01). The Atraucan needle had a more frequent EBP rate than the Sprotte or Whitacre needle (P = 0.05). Neither the PDPH rate nor the EBP rates differed among the pencil-point needles. The cost of EBP must be taken into consideration when choosing a spinal needle.
Postdural puncture headache (PDPH) is a frequent complication of spinal anesthesia. Some investigators have recommended the use of the Sprotte needle to reduce the incidence of this serious complication. Devcic et al. (25) prospectively compared the incidence of PDPH with two spinal needles of different size and design: the 24-gauge Sprotte (noncutting point) versus the 25-gauge Quincke (diamond, cutting point). The hypothesis that subarachnoid fentanyl will reduce the incidence of PDPH, as suggested in the literature, was also studied. Only patients for emergency or elective cesarean delivery were studied. One hundred ninety four patients were randomly assigned to receive spinal anesthesia with one of the two needles (Sprotte, n = 96; Quincke, n = 98). Simultaneously, each patient was assigned to receive hyperbaric 0.75% bupivacaine local anesthetic or a combination of the same concentration of local anesthetic with 20 micrograms of fentanyl (Sprotte with fentanyl, n = 47; Sprotte without fentanyl, n = 49; Quincke with fentanyl, n = 49; Quincke without fentanyl, n = 49). All patients were evaluated during the first 4 postoperative days, and follow-up telephone interviews were conducted 3 weeks after discharge. Four patients (4.2%) in the Sprotte group and seven (7.1%) in the Quincke group developed PDPH. Three out of four patients with headache in the Sprotte and four out of seven in the Quincke group received fentanyl as an adjunct for spinal anesthesia. Two patients in the Sprotte group required an epidural blood patch as a therapy for PDPH. Two patients in the Quincke group had severe headache and required an epidural blood patch. In the current study, the use of the 24-gauge Sprotte spinal needle resulted in a low incidence of severe PDPH, but was not significantly different when compared with the use of a 25-gauge Quincke needle (oriented parallel to the longitudinal dural fibers). The addition of fentanyl to hyperbaric bupivacaine spinal anesthesia did not reduce the risk of PDPH.
Reports have emphasized the importance of spinal needle tip configuration in the development of post dural puncture headache (PDPH). Charts from 366 consecutive obstetric patients receiving spinal anesthesia for labor, cesarean delivery, postpartum surgical procedures, or postpartum tubal ligations were reviewed retrospectively for evidence of PDPH in the five days after dural puncture (26). Spinal anesthesia was administered to these patients using 25-gauge Quincke (n = 74), 26-gauge Quincke (n = 160), or 24-gauge Sprotte (n = 132) spinal needles. The groups were well matched demographically. The incidence of PDPH in the three groups was 9%, 8%, and 1.5%, respectively. Half of the patients developing PDPH in each group were treated with an epidural blood patch. The Sprotte spinal needle, with its non-cutting tip, results in a significantly lower (p less than 0.05) incidence of PDPH than Quincke cutting-tip needles of smaller gauge.
One hundred and forty-four patients receiving subarachnoid anaesthesia for caesarean section were prospectively analysed for quality of anaesthesia and the occurrence of post dural puncture headache (PDPH) (27). Anaesthesia was administered via 24 gauge Sprotte (n = 104) and 26 gauge Quincke (n = 40) needles using hyperbaric bupivacaine 0.5% with morphine 0.2 mg. Anesthesia was successful in 103 patients with the Sprotte needle and 38 patients with the Quincke needle, and the operating conditions were considered to be excellent. Of the 104 patients in the Sprotte needle group there were ten with PDPH (9.6%), two of which were considered severe. Of the 40 patients in the Quincke needle group there were eight with PDPH (20%), three of which were considered severe. Despite the lower incidence of headache in the Sprotte needle group, this was not statistically significant (P > 0.05), due to the difference in population size.
Continuous spinal anesthesia
Continuous spinal anesthesia (CSA) fell into disuse because of a presumed high incidence of post dural puncture headache (PDPH). A careful retrospective study of 226 continuous spinal anesthetics administered for a variety of surgical (not obstetric) procedures was carried out and indicated that none of the patients developed PDPH (28). While 62% of the patients were older than 60 years of age, a group with a low incidence of PDPH, it was expected that some of the younger patients would develop this complication, especially since 94% of the dural punctures were carried out with 17- and 18-gauge needles. This study also revealed only a 12% incidence of hypotension, an impressive finding because 64% of the patients were considered ASA III or IV. There were no other intraoperative or postoperative complications or deaths due to CSA. This retrospective study indicates that CSA, properly carried out with 17- and 18-gauge needles, is not necessarily associated with a high incidence of PDPH; and in view of its low morbidity and mortality, CSA is particularly useful and safe in the poor-risk elderly patient.
To evaluate the incidence of postdural puncture headache (PDPH) associated with continuous spinal anesthesia, 200 male patients (mean age 65 years) were randomly assigned to receive spinal anesthesia in one of three ways: group 1, 50 patients with an 18-gauge Tuohy-Schliff needle/20-gauge catheter combination; group 2, 50 patients with a newly developed 20-gauge Quincke point needle/24-gauge catheter combination; and group 3, 100 patients (control group, single injection spinal anesthesia) with a 22-gauge Quincke point needle (29). Every patient was followed up for 7 days postoperatively. The incidence of PDPH was 6% with each continuous technique and 2% in the control group (difference not statistically significant). One group 1 patient who required an initial dose of 35 mg of tetracaine and 100 mg of lidocaine has a persistent, incomplete S4-5 sensory nerve deficit.
Young adult spinal anesthesia
Jeanjean et al. (30) assessed the occurrence of post-dural puncture headache (PDPH) in a group of young adults following spinal anaesthesia using a 24-gauge Sprotte needle in a prospective, multicentre, non-randomized study. This 9 month-long study, included 1,122 patients less than 50 years-old, consisting of 502 women and 620 men. Assessment of PDPH after 48 hours and 7 days. PDPH occurred in 0.8 percent of patients. There was no statistically significant difference in terms of age group or gender between the patients. Incidence of PDPH did not depend on type of anaesthetic solution, puncture level or ease of puncture. The use of 24-gauge Sprotte needles was associated with a low rate of puncture difficulties. Usual predisposing factors for PDPH, such as age below 50 years and female gender do no longer apply with this type of needle. The rate of puncture difficulties was low (6.7 percent), in contrast with ultra-fine 27 or 29 gauge needles, which sometimes result in puncture failure. Acceptance of the technique was excellent, as 99.38 percent of patients were satisfied.
In a prospective study of 80 patients under 40 years of age, given spinal anaesthesia through either a 0.52 mm (25-gauge) needle or a 0.33 mm (29-gauge) needle, the incidence of post-dural puncture headache and backache was compared (31). There were no headaches in the 0.33 mm needle group, while in the 0.52 mm needle group an incidence of 25% was found. The incidence of backache was the same in both groups. The technique of performing spinal anaesthesia was evaluated and concluded to be slightly more difficult with a 0.33 mm needle, as estimated by the number of redirections of the needle needed to obtain cerebrospinal fluid. There were no differences between the two needles with respect to obtaining adequate spinal anaesthesia and spread of blockade.
Brattebo et al. (32) compared a 24G Sprotte needle with a 27G Quincke needle in a randomised study of 200 healthy patients (49% females), aged 15-46 years. Four patients (2%) reported postdural puncture headache, three with the 24G Sprotte needle and one with the 27G Quincke needle. Thirteen patients (7%) suffered with nonspecific headache, with no significant difference between the two groups. Of the 57 (29%) who reported back pain, a significantly higher proportion had received spinal anaesthesia with the Sprotte needle (OR = 2.06). There was a significantly higher incidence of insufficient blocks after dural puncture with the Sprotte needle. Ease of needle insertion and number of puncture attempts was the same for both needle types.
The incidence of postdural puncture headache after spinal anesthesia with two types of 26- and 29-gauge needles was investigated in 149 patients less than 30 years old (33). Ten patients, (6.7%), six men and four women, developed typical symptoms of postdural puncture headache, while six (4.0%) developed headache of other origin. There were no headaches in the 29-gauge group. Spinal anaesthesia in four patients (8%) was impossible to perform with the 29-gauge needle.
One hundred patients aged 18-49 yr, undergoing elective arthroscopy of the knee joint, were allocated randomly to either spinal anesthesia using a 29-gauge spinal needle or general anesthesia (34). Dural puncture was considered difficult in 18% of the patients receiving spinal anaesthesia. In three patients (6%) it was necessary to supplement the spinal anesthetic with general anesthesia. Spinal and general anesthesia were otherwise uneventful in all patients. The incidence of postoperative headache was similar in the two groups. One patient developed post dural puncture headache following spinal anesthesia. This headache was of short duration and disappeared without treatment. Spinal anesthesia caused more backache than general anesthesia, otherwise the frequency of postoperative complaints was the same or lower. Ninety-six percent of the patients receiving spinal anesthesia would prefer the same anesthetic for a similar procedure in the future.
One hundred and six consecutive patients, aged below 40 years, scheduled for surgery in the lower part of the body were chosen by Knudsen et al. (35) for their study. Patients were allocated randomly to have spinal analgesia with either a Sprotte 24G or an Atraucan 26G spinal needle. Incidences of insufficient blocks were higher after dural puncture with the Atraucan needle. Nineteen patients reported post dural puncture headache (PDPH) with a significantly higher proportion in the Atraucan group (two patients suffered mild (4%) and 14 severe (98%) PDPH) compared to the Sprotte group (three patients suffered mild (6%) PDPH. Eight patients (16%), all in the Atraucan group, required an epidural blood patch. Ease of needle insertion and number of puncture attempts were the same for both needles.
A material of 100 patients aged 20-50 years was assessed after spinal analgesia with the Whitacre cannula G 25. None of the patients developed post-dural-puncture headache (36).
In a prospective study spinal anesthesia was performed in 500 patients (338 male and 162 female patients between 16 and 91 years of age: mean 46 years), with a total number of 603 spinal anesthetics (37). In all cases a 22G Whitacre needle was used. All patients were mobilized from the day of the operation onward and visited 4 days later by the interviewer and asked about any symptoms, especially headache. Mild postspinal headache occurred in 11 cases (1.8% of total), all in patients younger than 50 years of age and more in women. There were 6 patients among the 11 who did not need specific therapy for their headache; for the others antipyretic analgesics, adequate hydration and/or bed rest were satisfactory. The study shows that the incidence of postspinal headache was significantly reduced by the use of Whitacre's pencil-point needle in comparison with findings reported in the literature.
The incidence of postdural puncture headache (PDPH) following spinal anesthesia with a 0.33 mm (29-gauge) and two types of 0.7 mm (22-gauge) Whitacre needles was investigated in 400 patients less than 40 years old (38). The incidence of PDPH was 2% in the 0.33 mm group, and 3.5% in the 0.7 mm group. Headache of other origin was seen in 12 patients (6%) in the 0.33 mm and in five patients (2.5%) in the 0.7 mm group. These differences were not significant. The failure rate was significantly higher in the 0.33 mm group (8.5% vs 2%) than in the 0.7 mm group (P less than 0.05). It is concluded that the 0.33 mm needle is associated with a low incidence of PDPH in young patients, but has a significantly higher failure rate than the Whitacre 0.7 mm needle, which is also a suitable choice in this age-group because of its ease of handling and the low incidence of PDPH.
Wiesel et al. (39) designed a study to compare the frequency of postdural puncture headaches (PDPH) using the 24 gauge Sprotte and the 27 gauge Quincke spinal needles in a population of patients less than 45 yr of age undergoing spinal anesthesia for non-obstetrical surgery. Patients were randomly assigned to receive spinal anesthesia with either the 24 gauge Sprotte spinal needle (n = 46) or the 27 gauge Quincke spinal needle (n = 47). Patients were interviewed on either postoperative day one or two and on postoperative day three. A PDPH was defined as a headache involving the occipital or frontal areas that is made worse when assuming either the sitting or standing position. Ninety-three patients were included in the analysis of data. The overall incidence of PDPH was 14% (13 of 93), and no difference was found between the Sprotte (15.2%) and Quincke (12.8%) needles. The distribution of the PDPHs by severity was not different between the two groups. None of the 13 patients with PDPHs required an epidural blood patch for relief of symptoms. Both the Sprotte needle and the Quincke needles were judged as easy to use and both required the same number of attempts in order to locate cerebrospinal fluid (first attempt successful: 73.9% versus 66%). Neither patient satisfaction nor the acceptability of spinal anesthesia for a future procedure was adversely affected by the occurrence of a PDPH. The results of this study suggest that the risk of PDPH after spinal anesthesia in young patients is similar using either the 24 gauge Sprotte or the 27 gauge Quincke spinal needle.
Tarkkila et al. (40) compared the 24-gauge Sprotte and the 25-gauge Quincke needles with respect to post dural puncture headache and backache. Three hundred ASA Physical Status I or II patients scheduled for minor orthopedic or urologic operations under spinal anesthesia were chosen for this randomized, prospective study at a university hospital and a city hospital. Anesthetic technique, intravenous fluids, and postoperative pain therapy were standardized. Patients were randomly divided into three equal groups. Spinal anesthesia was performed with either a 24-gauge Sprotte needle or a 25-gauge Quincke needle with the cutting bevel parallel or perpendicular to the dural fibers. Anesthesia could not be performed in three cases with the Sprotte needle and in one case with the Quincke needle. The most common complications were post dural puncture backache (18.0%), post dural puncture headache (8.2%), and non-postural headache (6.7%). No major complications occurred. The Quincke needle with bevel perpendicular to the dural fibers caused a 17.9% incidence of post dural puncture headache. The Quincke with bevel parallel to the dural fibers and the Sprotte needles caused similar post dural puncture headache rates (4.5% and 2.4%, respectively). Other factors associated with post dural puncture headache were young age, early ambulation, and sedation during spinal anesthesia. There were no significant differences between needles in the incidence of post dural puncture backache.
Postdural puncture headache (PDPH) and backache are well known complications of spinal anaesthesia. The incidence of PDPH may be significant in young people (< 50 years). Eriksson et al. (41) compared the utility and complication rate of the Whitacre and Ouincke spinal needles. During three years all patients who could comply, and who were to undergo spinal anesthesia at the Department were asked to join this quality control study. Each one received a questionnaire including questions about discomfort and other possible side effects attributed to spinal anesthesia. In each case, an extended anesthetic record was filled out by the anesthesiologist. About 50 anesthesiologists at different educational levels were involved. The study includes 2598 cases, of which questionnaires were returned by 66%. Needles of the 25 G gauge size were used in over 90% of the cases. Multiple skin punctures were required more frequently in the Quincke than in the Whitacre group (P < 0.01). The number of insufficient blocks was also higher in the Quincke group (P < 0.01). There was a higher incidence of backache in the Quincke group (P < 0.05). In patients under 50 years, PDPH was more frequent following use of the Quincke needle (P < 0.05), whereas no difference between the needles in this regard was found among those over 50 years (P > 0.05).
In a prospective study of 300 young orthopaedic in-patients (less than 40 years) given spinal anesthesia through a 22-gauge Whitacre (n = 150) or a 25-gauge Quincke spinal needle (n = 150), Lynch et al. (42) found a 5.3% and a 9.3% incidence of post-spinal headache (PSH) respectively. Females (10.6%) had a higher overall incidence of post-spinal headache than males (5.6%) with more than twice as many females being affected in the 25 than in the 22-gauge group (14.5% vs 6.1%). The average duration of post-spinal headache was less in the 22-gauge group (36 h vs 42.4 h) as was the incidence of severe headache. The Whitacre 22-gauge needle was more suited for spinal analgesia in young female patients due to its ease of handling and its lower incidence of post-spinal headache.
Dich-Nielsen and Hansen (43) studied 75 patients aged 15-40 years who received spinal anesthesia with the Sprotte 24-gauge spinal needle. The incidence of post dural puncture headache was 4%. Other types of headache occurred in 8% of the patients. The patient acceptance was high.
Spinal anesthesia under the microscope
An in vitro examination of 25-gauge Quincke and 25-gauge and 27-gauge Whitacre spinal needles was performed after insertion in 210 consenting adult patients (44). In addition, 300 unused Quincke needles and 300 unused pencil-point needles were examined under a dissecting microscope. When the microscopic evaluation was performed on the needles after spinal blockade, burrs or blunting of the needle tip were noted in 24% of the Quincke needles compared with only 3% of the 25-gauge Whitacre needles and 10% of the 27-gauge Whitacre (P < 0.05). Bony contact with 25-gauge Quincke and 27-gauge Whitacre needles resulted in an increased incidence of microscopic tip damage (versus 25-gauge Whitacre). Needle-tip damage with the Whitacre needles was limited to blunting of the tip. The analysis of unused needles revealed significant differences among manufacturers of the cut-bevel needles with respect to stylet-to-needle length and burrs on the end of the stylet. The leading edge of the stylet protruded beyond the opening of the needle tip in 7% of the Quincke needles. However, only minor needle-tip abnormalities were noted with the pencil-point needles (i.e., variability in the side-port opening to needle tip distance, side-port opening integrity). Bony contact produced more damage to the cut-bevel than to the pencil-point needle tips. In addition, fewer inherent manufacturing defects were noted with the pencil-point versus cut-bevel needles. It has been suggested that damaged needle tips may contribute to a higher incidence of headaches after spinal anesthesia. A microscopic examination revealed that the pencil-point (versus cut-bevel) needles had fewer manufacturing flaws and were less susceptible to tip damage when bony contact occurred during the placement of the spinal needle.
The structure of the spinal dura mater and the consequences of puncturing the dural tissue with different types of spinal needles were examined (45). There is no uniformly longitudinal parallel arrangement of dural fibers in human lumbar dura mater from the segments L3-5, but as shown in both scanning electron microscope imaging and polarized light microscopy the small collagenous fibrils are connected by cross-linked bridges. After perforation with Whitacre's pencil-point needle a kind of double layer membrane surrounds the puncture hole and might be responsible for the rearrangement of dural fibers and sealing of the hole after removal of the needle, like wings closing over each other (curtain-effect). This double layer membrane was not seen after dural puncture with sharp Quincke-bevelled needles.
Atraucan 26-gauge spinal needles have a tip designed to make a small linear cut (as opposed to a V-shaped cut) in the dura mater. The cut is shorter than the outside diameter of the needle and is dilated as the needle passes through the dura. The needle is used with a 20-gauge introducer. In vitro, it causes less leakage of cerebrospinal fluid than Quincke 26-gauge or Sprotte 24-gauge needles. Scott et al. (46) designed a study to test the ease of use and any damage caused to the needle tip during lumbar dural puncture. This was a multicenter trial (six centers in five countries) involving 362 patients undergoing spinal anesthesia. A detailed questionnaire was filled in for every patient by the anesthesiologist. All the needles were returned to the factory and examined microscopically for damage. Lumbar dural puncture was successful in all but one patient. Spinal anesthesia was satisfactory for the planned surgery in 97%. Microscopy of the needle tips showed only a minor degree (0.01-0.19 mm) of bending in 14%, and none of the tips had a "hook." Postdural puncture headache (PDPH) occurred in nine patients (2.5%), all but one of whom (a 15-year-old male) were females under 55 years of age.
Reina et al. (47) studied dural lesions caused by the Whitacre 25 G and Quincke 26 G needles, using scanning electron microscopy with the aim of determining whether there is an anatomic basis for the different outcomes regarding PDPH. The dura mater from three fresh cadavers of individuals aged 65, 70 and 72 years were punctured 40 times at an angle of 90 degrees each time. The Whitacre 25 G needle was used for 20 punctures and the Quincke 26 G needle was used for the other 20. Half the punctures were performed with the bevel in the parallel alignment and the other half with the bevel perpendicular to the spinal column. Fifteen min after causing the punctures, specimens were fixed in solutions of glutaraldehyde phosphate buffer and dehydrated in acetone. After critical point removal of the acetone, after the specimens were treated with carbon and metallized with gold, the lesions were examined externally and internally and expressed as the ratio of area of lesions to the diameter of the needle that had caused them. Whitacre needle: each lesion consisted in the superimposition of multiple damaged layers that started to close individually. After 15 min the outermost layers were 90% closed and the innermost ones had closed entirely. Layers in the arachnoid surface of the dura mater had closed from 86 to 88%, while deeper layers in the thick part had closed 97 to 98%. Quincke needle: lesions were V-shaped or half-moon shaped, much like the opening formed by a can opener, on both the external and internal surfaces. Alignment of the bevel of the needle parallel to the spinal column did not lead to a different shape of puncture. After 15 min the lesions had closed 94 to 95% on the epidural surface and 95 to 96% on the arachnoid side, a difference attributable to the retraction of the arachnoid layers over the spinal column. Non traumatic beveled dural needles, termed "pencil point needles", only partially separate dural fibers, and lesions caused by these needles develop in a more complex way. The Quincke 26G needle produced a puncture that is morphologically different from that caused by the Whitacre 25G needle, although lesions produced by both types close more than 94% after 15 min. The size of the lesion caused by these needles does not explain the difference in post dural puncture headache due to loss of spinal fluid.
A study using scanning electron microscopy showed that although the laminas forming the dura mater are concentric and parallel to the surface of the medulla, the fiber layers' orientations are different in each sub-lamina, dispelling the conventional knowledge that all the fibers of the dura are arranged in a parallel direction. Reina et al. (48) evaluated the dural lesions produced by Whitacre and Quincke spinal needles in the external and internal surface of the dura mater of the lower spine area in an attempt to gain more insight into the pathophysiology of postdural puncture headaches (PDPH). The T11-L4 dural membranes from 5 fresh (immediately after extraction of organs for transplantation), male patients declared brain dead, ages 23, 46, 48, 55, and 60 years, were excised by anterior laminectomy. Morphologic orientation of the membrane and normal pH were maintained with an apparatus designed for this purpose. One hundred punctures (20 on each sample) at 90-degree angles were done with a new needle each time, 50 with 25-gauge Whitacre and 50 with 25-gauge Quincke needles. Half of the punctures with the Quincke needles were done with the bevel in parallel direction to the axis of the spinal cord, and the rest with the bevel perpendicular to it. Fixation in solutions of 2.5% glutaraldehyde phosphate buffer, followed by dehydration with acetone, was done 15 minutes after the punctures. After acetone was removed at ideal conditions of temperature and pressure, the specimens were then metallized with carbon followed by gold and inspected under a scanning electron microscope. Twenty-five of the Whitacre and 23 of the Quincke punctures were found for evaluation. There were no differences in the cross-sectional area of the punctures produced by the Whitacre or Quincke needles on the dura. The area of the dural lesions produced by 25-gauge Quincke needles, 15 minutes after they have been withdrawn, was 0.023 mm2 (confidence interval [CI] 95%, 0.015 to 0.027) in the external aspect (epidural surface) and 0.034 mm2 (CI 95%, 0.018 to 0.051) in the internal aspect (arachnoid surface) of the dural sac. The area of the lesions produced by the 25-gauge Whitacre needles was 0.026 mm2 (CI 95%, 0.019 to 0.032) and 0.030 mm2 (CI 95%, 0.025 to 0.036) in the external and internal surfaces of the dural sac, respectively. There were no significant differences in the cross-sectional areas of the punctures produced by the 25-gauge Whitacre or 25-gauge Quincke needles. Moreover, with Quincke needles the dural lesions closed in an 88.3% (CI 95%, 86.3 to 92.4) and 82.7% (CI 95%, 74.1 to 90.9) of their original sizes in the epidural and arachnoid surfaces, respectively. With Whitacre needles, the closure occurred in an 86.8% (CI 95%, 83.8 to 90.3) and 84.8% (CI 95% 81.7 to 87.3) in the dural and arachnoid surfaces, respectively. However, there were differences in the morphology of the lesions. The Whitacre needles produced coarse lesions with significant destruction in the dura's fibers while the Quincke needles produced a 'U'-shaped lesion (flap) that mimics the opened lid of a tin can, regardless of the tip's direction. The needles produced lesions in the dura with different morphology and characteristics. Lesions with the Quincke needles resulted in a clean-cut opening in the dural membrane while the Whitacre needle produced a more traumatic opening with tearing and severe disruption of the collagen fibers. Thus, it was hypothesized that the lower incidence of PDPH seen with the Whitacre needles may be explained, in part, by the inflammatory reaction produced by the tearing of the collagen fibers after dural penetration. This inflammatory reaction may result in a significant edema which may act as a plug limiting the leakage of cerebrospinal fluid.
Combined spinal-epidural anesthesia
Herbstman et al. (49) evaluated four pencil-point spinal needles commonly used for combined spinal-epidural (CSE) anesthesia. Four hundred-seven consecutive parturients undergoing cesarean delivery or labor analgesia received a CSE block with a randomly selected pencil-point spinal needle (Becton-Dickinson [B-D] 27-gauge, 119-mm Whitacre; B-D 27-gauge, 120-mm Durasafe; B-D 25-gauge, 120-mm Durasafe; or International Medical Devices' 26-gauge, 124-mm Gertie Marx). Success in obtaining cerebrospinal fluid (CSF) and the incidence of transient paresthesias and postdural puncture headache (PDPH) were compared by using chi2 testing; P < 0.05 was considered significant. Failure to obtain CSF (3%-5%) was not significantly different among spinal needles. The Gertie Marx 26-gauge needle was associated with significantly more paresthesias (29%) than the Whitacre 27-gauge needle (17%). The combined incidence of paresthesias with the Durasafe 25-gauge and Gertie Marx 26-gauge spinal needles (28%) was greater than the combined incidence of paresthesias with the Durasafe 27-gauge and Whitacre 27-gauge needles (18%). The incidence of PDPH did not differ among the four pencil-point spinal needles. The use of four pencil-point spinal needles in the combined spinal-epidural technique is associated with an inconsequential incidence of spinal headache, a low incidence of paresthesias that are transient with no long-term effects, and a high degree of success independent of spinal needle length.
Needle size and shape may influence the incidence of paresthesias, post-dural puncture headache and other complications during combined spinal-epidural (CSE) procedures. Landau et al. (50) have noted a relatively high incidence of transient paresthesias during placement of the spinal needle during CSE for labor analgesia. The purpose of their study was to compare the occurrence of paresthesia and post-dural puncture headache in parturients who received CSE analgesia with either a 25-gauge or 27-gauge Whitacre needle. In a prospective observational study, data were gathered from 478 consecutive women receiving labor analgesia. Incidence, duration, and character of any paresthesias upon spinal needle placement and the incidence and treatment of headache were recorded. The incidence of paresthesia with the two needles was similar (16% with 25-gauge vs15.4% with 27 gauge) but the incidence of post-dural puncture headache was higher with the 25-gauge needle (4% vs 0.7% with 27 gauge, P<0.05). This data suggest that with Whitacre needles, 27-gauge might be preferable to 25-gauge needles to reduce the rate of post-dural puncture headache in parturients but that they do not alter the incidence of transient paresthesias.
An in vitro model was used to determine the force required to pierce bovine dura with a range of new spinal needles and to measure the subsequent leakage rate of cerebrospinal fluid (CSF) (51). A significantly greater force was required to pierce the dura with pencil-point style needles compared to Quincke needles of the same size. Quincke needles caused a greater loss of CSF than their pencil-point equivalents. The results suggest that there is not likely to be a significant reduction in postdural puncture headache (PDPH) using a 27-gauge pencil-point needle compared to a 25-gauge needle that may be easier to use. Different makes of the same design and gauge of needle showed significant differences in the amount of CSF leakage, which may influence the clinician's choice of needle.
Leakage of artificial cerebrospinal fluid through human dura was measured in vitro after puncture by spinal needles (52). Fluid loss tailed off in all cases and ceased within 5 minutes in 10% of punctures made with a 22-gauge needle, 28% made with a 26-gauge and 65% made with a 29-gauge needle (p less than 0.05). The fluid loss was not reduced by alignment of the level of the needle parallel to the longitudinal direction of the fibres. Whitacre point needles of 22 gauge produced lower fluid loss than a 22-gauge Quincke point needle inserted across the fibres (p less than 0.05). Leakage rate was related to needle size, but not related to the alignment of a Quincke point. Little or no leakage occurred with 29-gauge needles.
Lynch et al. (53) examined the incidence of failed spinal anesthesia and postdural puncture headache using a 27-gauge Whitacre and a 27-gauge Quincke needle in patients undergoing elective inpatient orthopedic procedures. The overall rate of failed spinal anesthesia was 8.5% [95% confidence interval (CI) = 4.6%-12.4%] (n = 17) in the Quincke group (n = 199) and 5.5% [95% CI = 2.3%-8.7%] (n = 11) in the Whitacre group (n = 199). This difference was not statistically significant. The overall incidence of postdural puncture headache (PDPH) was 0.8%; 1.1% [95% CI = 0%-2.4%] (n = 2) in the Quincke group and 0.5% [95% CI = 0%-1.5%] (n = 1) in the Whitacre group. These differences were not statistically significant. All headaches were classified as mild and resolved spontaneously with conservative management. The mean time for withdrawal of the stylet to appearance of cerebrospinal fluid was 10.8 +/- 6.9 s in the Quincke (n = 31) and 10.7 +/- 6.8 s in the Whitacre group (n = 33). These differences were not statistically significant. These results suggest that both needles are associated with a very low incidence of PDPH and an incidence of failed anesthesia of 5.5%-8.5%.
Pan et al. (54) compared the incidence of postdural puncture headache (PDPH) and postdural puncture backache (PDPB), and the success rate between two small-gauge spinal needle designs used in women undergoing subarachnoid block anesthesia. After Institutional Review Board approval, 215 patients presenting for tubal ligation were randomly assigned to have 26-gauge Atraucan (AT group) or 25-gauge Whitacre (WH group) spinal needles used in their spinal anesthesia. The number of attempts to successful cerebrospinal fluid return and the success rate of the spinal blockade were documented. Postoperatively, an investigator blinded to the study interviewed patients daily. The incidence of PDPH was similar between the AT group (3.9%) and the WH group (4.0%). The total duration of all PDPHs was 5 days for the AT group and 15 days for the WH group. Both groups had a similar one-attempt success rate of 61% (AT group) and 62% (WH group). Failure to obtain cerebrospinal fluid occurred in only one in the AT group and two in the WH group. The incidence of PDPB was similar and the severity was mild in both groups. The low complication and failure rates make these two types of smaller size spinal needle design good candidates for dural puncture procedures, such as spinal anesthesia, diagnostic lumbar punctures, and myelograms.
Ninety-six women undergoing post-partum tubal ligation under spinal anesthesia were studied to compare 26G Atraucan with 25G Whitacre spinal needles for ease of insertion, number of attempts at needle insertion, cerebrospinal fluid (CSF) flow characteristics through the needles, quality of subsequent analgesia, and incidence of perioperative complications (55). A higher rate of successful dural puncture at the first attempt (40/50 vs 27/46, P < 0.05) and faster (mean +/- SD, 11.5 +/- 2.2 vs 13.5 +/- 2.4, P < 0.001) CSF flow through the needle was achieved with the Atraucan than with the Whitacre needle. The incidence of failed spinal (4% vs 5%) and post-dural puncture headache (PDPH) (4% vs 4.3%) was similar with both needles, but more patients experienced paresthesia during needle insertion with the Whitacre than with the Atraucan needle (15% vs 2%, P < 0.05). It was concluded that the use of the 26G Atraucan needle is associated with a higher rate of successful identification of the subarachnoid space at the first attempt, faster CSF backflow, and fewer paresthesia when compared with the 25G Whitacre needle.
Sakuramoto (56) evaluated the insertion characteristics and complications of a new spinal needle 26-gauge Atraucan (group A) compared with 27-gauge Whitacre (group W) in 100 patients undergoing orthopedic surgeries of the lower extremities. Spinal anesthesia was performed in the lateral decubitus position and 0.40-0.5% tetracaine 1.6-2.5 ml was injected through the L 3/4 or L 4/5 interspace. The tactile appreciation of dural presentation with the needle (dural click) was higher in group W (89.8%) than in group A (42.6%). The back flow of cerebrospinal fluid was not recognized within three punctures in 2 cases (4%) in group A and in 1 case (2%) in group W. In these 3 cases, spinal anesthesia was performed easily using 25-gauge Whitacre. In group A, the spinal needle could be inserted without using an introducer in 35 cases (70%). The incidence of the postoperative headache or back pain was low and postdural puncture headache (PDPH) did not occur in both groups.
The PENCAN 25-gauge spinal needle is a new pencil-point needle with an inner diameter of 0.32 mm resulting in a relatively high cerebrospinal fluid (CSF) flow. The PENCAN 25-gauge needle was tested for ease of identification of a successful dural puncture, the failure rate of spinal anesthesia, and the incidence of postdural puncture headache (PDPH) (57). In a multicenter trial, the needle was tested in patients undergoing spinal anesthesia. A questionnaire evaluated the characteristics of the dural puncture. A second questionnaire was used to assess postspinal side effects (PDPH, atypical headache, audiovisual disturbances). In 1,193 patients, dural puncture was evaluated as easy in 85.2%, as moderate in 6.2%, as difficult in 6.7%, and as impossible in 1.9%. Needle performance was assessed as excellent or satisfactory in 96.9%. In 95.9% of patients, CSF appeared within 2 seconds. A perceptible "click" was noticed in 78.4% of patients. In 1.9%, CSF could not be obtained, because of spine deformities, obesity, or bending of the needle. In 1,166 patients, postpuncture complaints were evaluated, involving 635 women (54.5%), 773 patients (66.3%) under the age of 50 years old, and 170 (14.6%) cesarean deliveries. The overall incidence of PDPH was 1.3% (n = 15). A bloodpatch was needed in five patients. After cesarean delivery the incidence of PDPH was 3.4%, all responding to conservative treatment. Atypical headache and isolated audiovisual disturbances occurred in 7.5% and 1.5% of patients, respectively.
Previous studies have failed to find a significant correlation between the number of dural punctures and the incidence of postdural puncture headache (PDPH), questioning the hypothesis that leakage of cerebrospinal fluid (CSF) through the dural tear is the cause of PDPH. Seeberger et al. (58) hypothesized that insufficient statistical power of these studies was the cause for this unexpected finding, and re-examined whether repeated dural punctures increase the incidence of PDPH by analyzing prospectively collected data on 8034 spinal anesthetics. Uneventful spinal anesthetics, including a single subarachnoid injection of local anesthetics, occurred in 7865 (97.9%) cases, whereas failed spinal anesthetics requiring repeated dural puncture for a second subarachnoid injection of local anesthetics occurred in 165 (2.1%) cases. The two groups were similar with regard to age, sex, and ASA physical status. They found that repeated dural punctures significantly increased the incidence of PDPH. It was concluded that increased risk of PDPH is a disadvantage of performing a second subarachnoid injection of local anesthetics after a failed spinal anesthetic. Moreover, this result suggests that leakage of CSF through the dural tear is the most plausible cause of PDPH.
Spinal anesthesia developed in the late 1800s with the work of Wynter, Quincke and
Morewood (60) reviewed the current research and formulate a rational approach to the cause, prevention and treatment of postdural puncture headache (PDPH). Articles published from January 1980 to April 1992 were obtained through a search of MEDLINE and Index Medicus. Key reference articles published before 1980 were also reviewed. All pertinent studies were included and critically analysed. PDPH occurs when a slow leak of cerebrospinal fluid leads to contraction of the subarachnoid space and compensatory expansion of the pain-sensitive intracerebral veins. Female sex and an age between 20 and 40 years have been shown to be independent risk factors for PDPH, but pregnancy has not. The rate of PDPH is directly proportional to the diameter of the needle used and also depends on the design of the needle tip. Prophylactic epidural blood patching or saline infusion after dural puncture can decrease the incidence of PDPH, but both are invasive procedures. Intravenous caffeine sodium benzoate therapy effectively relieves PDPH, but the headache may recur. An epidural blood patch is an invasive but effective, permanent treatment for PDPH in most cases; resistant cases may respond to epidural saline infusion. The rate of PDPH after lumbar puncture can be minimized through strict attention to technique and the employment of a 25-gauge needle with the bevel parallel to the dural fibres.
Shutt et al. (61) have studied 150 women undergoing elective Caesarean section under spinal anesthesia. They were allocated randomly to have a 22-gauge Whitacre, a 25-gauge Whitacre or a 26-gauge Quincke needle inserted into the lumbar subarachnoid space. The groups were compared for ease of insertion, number of attempted needle insertions before identification of cerebrospinal fluid, quality of subsequent analgesia and incidence of postoperative complications. There were differences between groups, but they did not reach statistical significance. Postdural puncture headache (PDPH) was experienced by one mother in the 22-gauge Whitacre group, none in the 25-gauge Whitacre group and five in the 26-gauge Quincke group. Five of the six PDPH occurred after a single successful needle insertion. Seven of the 15 mothers in whom more than two needle insertions were made experienced backache, compared with 12 of the 129 receiving two or less (P < 0.001). It was concluded that the use of 22- and 25-gauge Whitacre needles in elective Caesarean section patients is associated with a low incidence of PDPH and that postoperative backache is more likely when more than two attempts are made to insert a spinal needle.
Schultz et al. (62) evaluated whether the 26-gauge Atraucan needle shows any benefit on the incidence of postdural puncture headache (PDPH) and back pain as compared with the 27-gauge Quincke needle. They investigated 388 patients, 171 men and 217 women, who were receiving spinal anesthesia for subumbilical surgery. They compared spinal anesthesia via the 27-gauge Quincke needle in 202 patients (group Q) and via the 26-gauge Atraucan needle in 186 patients (group A). The incidence of PDPH was 2.97% (6 of 202) in group Q and 2.69% (5 of 186) in group A. The incidence of back pain was 4.95% (10 of 202) in group Q and 5.91% (11 of 186) in group A. There was no statistically significant association of needle type, age, or sex with the incidence of PDPH and back pain.
Lynch et al. (63) studied 200 orthopaedic inpatients (111 males) aged 15-84 yr who received spinal anesthesia with one of two types of Whitacre spinal needle: 22-gauge or 25-gauge. The incidence of headache, backache, failure of spinal anesthesia and patient acceptability was investigated using a questionnaire. The incidence of postdural puncture headache (PDPH) was 4% in the 22-gauge group and 2% in the 25-gauge group. The incidence of backache and headache of other origin was similar in both groups. Spinal anesthesia was carried out successfully in all patients in both groups. Patient acceptance was high (98%) and there were no serious complications observed.
In a prospective study lumbar iohexol myelography was performed in 107 consecutive patients, randomised for lumbar puncture with a Quincke or Whitacre spinal needle (64). All patients answered a questionnaire about possible side effects. Data from 100 patients (58 men, 42 women) were evaluated. In the Quincke group (n = 53), 23 (43%) reported no side effects. In the 30 patients who reported various side effects, post-dural puncture headache (PDPH) occurred in 22 (42%), of whom 9 had mild, 6 moderate and 7 (13%) severe cephalalgia, 18 (34%) reported increased low back pain/sciatica, 5 nausea and 7 dizziness. In the Whitacre group (n = 47), 33 (70%) had no side effects. PDPH was reported by 9 patients (19%), of whom 2 had mild, 6 moderate and only 1 (2%) severe cephalalgia, 4 (9%) reported increased low back pain/sciatica, 5 nausea and 4 dizziness.
The effect of different size (25-, 27- and 29-gauge) Quincke-type spinal needles on the incidence of insertion difficulties and failure rates was investigated in a randomised, prospective study with 300 patients (65). The needle size was randomised but the insertion procedure was standardised. The time to achieve dural puncture was significantly longer with the 29-gauge spinal needle compared with the larger bore needles and was due to the greater flexibility of the thin needle. However, the difference was less than 1 min and cannot be considered clinically significant. There were no significant differences between groups in the number of insertion attempts or failures and the same sensory level of analgesia was reached with all the needle sizes studied. Postoperatively, no postdural puncture headaches occurred in the 29-gauge spinal needle group, whilst in the 25- and 27-gauge needle groups, the postdural puncture headache rates were 7.4% and 2.1% respectively. The incidence of backache was similar in all study groups.
Attempts have been made to reduce the incidence of postdural puncture headache (PDPH) after spinal anesthesia by changing the size and design of the needle. Halpern and
Spinal needles with a pencil-point tip and those of a finer gauge are known to be associated with a lower incidence of postdural puncture headache. Smith et al. (67) studied if fine pencil-point needles were acceptably easy to use in routine clinical practice. Two hundred and twelve women undergoing elective Cesarean section were randomly allocated to receive a subarachnoid block using either a 25 G or 27 G Whitacre needle. Factors determining ease of needle use, adequacy of block, incidence of postdural puncture headache, backache and neurological sequelae were assessed. Successful intrathecal injection was achieved in all patients in the 25 G group. Using the 27 G needle, the anaesthetist failed to reach the subarachnoid space in eight patients of which seven subsequently had a successful intrathecal injection with a larger needle. These failures were attributed to excessive needle flexibility which was the only significant difference in ease of use between the 25 G and 27 G needles. In the 25 G group, there was one severe postdural puncture headache which required an epidural blood patch and three mild headaches which resolved spontaneously. There were no postdural puncture headaches in the 27 G group. It was concluded that the final choice of needle is a compromise between the ease of use and lower failure rate of the 25 G needle and the, as yet unproven, possibility of a lower incidence of postdural puncture headache with the 27 G needle.
Flaatten et al. (68) conducted a study in order to investigate the effect of two different orientations of the bevel during dural puncture on development of postural postdural puncture headache (PPDPH). Two hundred and eighteen patients aged 18 to 50 years scheduled for minor non-obstetric surgery using spinal anesthesia (SA) were included in this randomised, double-blind study. Dural puncture was performed using a 0.42 mm O.D. (27-g) Quincke spinal needle with the orientation of the bevel parallel or transverse relative to the longitudinal axis of the dural cylinder. All patients were blinded with regard to the puncture technique, and so was the anesthesiologist performing a telephone interview 5 to 7 days postoperatively. The occurrence and duration of headache, backache and other complaints were recorded. Headache was classified as PPDPH or non-PPDPH, and intensity of the headache was registered using a numerical rating scale (NRS) from 0 to 10. Two hundred and twelve patients with a mean age of 35.3 years completed the study, 106 in each group. The two groups were comparable with regard to mean age, sex, local anesthetics used and surgical procedure performed. Headache occurred in 44 patients postoperatively. PPDPH was diagnosed in 4/106 patients (3.8%) in the parallel group and 24/106 (22.6%) in the transverse group (P < 0.0002). Postoperative backache occurred in 31 and 20 patients (parallel compared to transverse) (NS). Dural puncture with the bevel of the needle transverse to the longitudinal axis of the dural cylinder gave significantly more cases of PPDPH than puncture with the bevel parallel to this axis even when using a 27-g Quincke needle.
Flaatten et al. (69) compared the incidence of postural post-dural puncture headache (PPDPH) after spinal anesthesia using two different 0.40 mm O.D. (27 g) spinal needles: pencil-point needle and Quincke needle. In addition, a meta-analysis of studies comparing small bore spinal needles with regard to development of PPDPH was performed. A prospective randomised double-blind study was set up to investigate PPDPH after using 0.40 mm pencil-point (Pencan, B. Braun) or Quincke (Spinocan, B. Braun) spinal needle. Postoperatively on day 5 to 7 a telephone interview was conducted in order to reveal postoperative complications such as headache and backache. PPDPH was considered present when the headache was new to the patient, and demonstrated posture dependence. Electronic database search and manual search of relevant literature were performed in order to find randomised control trials comparing equal sized (outer diameter, O.D.) spinal needles with different bevel shape. Only studies with a proper method and not merely presented as an abstract were included in addition to the present clinical study. Out of 313 patients randomised, 301 were completely followed up, 153 in the pencil-point group and 148 in the Quincke group. The two groups were comparable regarding surgical procedures and demographic data. Of 15 patients suffering from PPDPH, 12 were found in the Quincke group, and 3 in the pencil-point group. The difference was 6.1% (95% CI from 1.2 to 12.5%). The meta-analysis of 1131 patients gave a relative risk of developing PPDPH of 0.38 (95% CI from 0.19 to 0.75) in the pencil-point group compared to the Quincke group. It was concluded that a pencil-point-shaped spinal needle will significantly reduce PPDPH compared with Quincke-type spinal needles, also when small bore needles (0.40 mm O.D.) are used.
A clinical survey was conducted on 274 patients who had surgery under subarachnoid spinal anesthesia (70). The anesthetic was performed with either a 23 gauge or 25 gauge needle. All patients were interviewed on the second and sixth post-operative days. Data on morbidity (especially post-dural puncture headache and backache) was collated and analysed with respect to needle gauge. Backache was the most common complaint (20.5%). Using the finer needle did not reduce this aspect of morbidity. Post-dural puncture headache on the other hand was significantly reduced by the use of the finer 25 gauge needle (from 12.3% to 4.9%).
Post-dural puncture headache and lumbar backache are related to needle gauge and type of point used. Morros-Vinoles et al. (71) aimed to determine whether the incidence of post-dural puncture headache and lumbar backache could be reduced by using fine gauge pencil-point Sprotte 27G and 29G needles. They also studied increases in technical difficulty with these needles and whether or not reducing needle gauge affected anesthetic quality. Three hundred eighty-nine patients undergoing orthopedic or lower abdominal surgery were randomly assigned to two groups for dural puncture using two Sprotte needles: 27G or 29G. They recorded time to perform puncture, number of re-insertions of the needle, number of times the technique was abandoned and anesthetic efficacy. On the second and seventh days, the patients were interviewed by telephone to check for the presence and severity of post-dural puncture headache or lumbar backache. The technical difficulty was greater with the Sprotte 29G needle, as shown by significant differences in time taken to perform the puncture and the number of re-insertions (p < 0.05). Anesthetic quality was the same in both groups and the percentage of failures was 0.5% for both. Five percent of patients in the 27G group and 3% in the 29G group experienced slight or moderate headache on the second day. No cases of severe headache were reported. Lumbar backache was reported on the second day by 26% and 18.5% of the patients in the 27G and 29G groups, respectively, but the rates decreased to 4.5% and 0.5% on the seventh day. The differences were significant, favoring the 29G needle. The use of 29G pencil-point needles can be recommended to reduce the incidence of headache and lumbar backache in the postoperative period, in spite of the greater technical difficulty involved, given that quality of anesthesia is maintained.
Flaatten et al. (72) conducted a study in order to investigate the effect of patient expectation in the development of postural post-dural puncture headache (PPDPH). 224 patients less than 55 years scheduled for minor non-obstetric surgery were randomised to receive single-injection spinal (SA) or epidural (EA) anesthesia. A 27-g Quinke needle was used for SA and a 18-g Tuohy needle for EA. Patients, operating team and postoperative ward personnel were all blinded to the anesthetic given and so was an independent observer responsible for follow-up after 5-7 days. The occurrence of headache, backache and other complaints was recorded. Headache was classified as PPDPH or non-PPDPH, and duration and intensity of the headache was registered. The quality of anesthesia was directly evaluated by the surgeon using a VAS scale from 1 (excellent) to 10 (very poor) and indirectly by the supplemental use of opioid analgesia and general anesthesia in the two groups. 212 patients, 103 SA and 109 EA, with a mean age of 36.7 years, could be fully evaluated. The groups were comparable with regard to age, sex and surgical procedure performed. Headache occurred in 44 patients postoperatively. PPDPH was diagnosed in 16 patients (15.5%) in the SA group and 2 (1.8%) in the EA group (P = 0.0014). Non-PPDPH occurred in 13 patients in each group. PPDPH had significantly greater mean intensity and duration than non-PPHPH. More patients in the EA group had postoperative backache (31.2%) than in the SA group (22.3%), but this difference was not statistically significant. More patients in the EA received general anesthesia and opioid analgesia than in the SA group, and the surgeon's rating was on average 1.3 in the SA group compared to 2.5 in the EA group (P = 0.0003). SA gave more headache but superior quality of surgical anesthesia compared with EA. Dural puncture, and not expectation, is the major cause of PPDPH.
Peterman (73) compared the postdural puncture headache (PDPH) rates after myelography with use of 22-gauge Whitacre (blunt tip) versus standard 22-gauge Quincke (bevel-tip) spinal needles. At myelography, 340 patients were randomly assigned to one of two groups in which either the Whitacre (167 patients) or the Quincke (173 patients) needle was used. Follow-up was at 48 hours and at 4 days after the procedure. Crude and adjusted Whitacre/PDPH odds ratios and risk ratios were calculated. The crude Whitacre needle PDPH risk was 9.6%, and the crude Quincke needle PDPH risk was 15.6%. The absolute risk difference was 6.0% with a 95% confidence interval of -0.98% and 13.04%. The adjusted Whitacre/PDPH odds ratio was 0.492 with a 95% confidence interval of 0.241 and 1.003. The Whitacre needle group had a statistically significantly lower PDPH severity grade (P = .0151), similar PDPH duration, and more technical difficulty with the needle.
Quaynor et al. (74) studied 63 patients between the ages of 20 and 81 years undergoing lumbar myelography, using a 25-gauge pencil-point (Whitacre) spinal needle. With the use of a questionnaire, the incidence and severity of post-dural-puncture headache (PDPH) was investigated. There were three patients who complained of PDPH (4.7%), two of whom described their headache as moderate and one as mild on a visual analogue scale. All the headaches were alleviated by mild analgesics and no patient experienced severe headache needing treatment with a blood-patch. There were three other patients who experienced a post dural-puncture-related headache which, unlike PDPH, was not postural. Four patients had ordinary mild headache. The quality of the myelograms was good.
Flaatten et al. (75) conducted a study to investigate complications after dural puncture. A 15 months' prospective observation study of routine clinical practice with dural puncture at a university hospital was conducted. Quincke spinal needles 0.90 to 1.0 mm O.D. (20-19 g) were used for diagnostic lumbar puncture, 0.70 mm O.D. (22 g) for myelography and 0.40 to 0.50 mm O.D. (27-25 g) for spinal anesthesia. A questionnaire about post-puncture discomfort was given to the patients, to be returned after 1 week. Of 679 questionnaires 537 (79.1%) were returned. Discomfort was experienced by 53.8% of the patients, most often after diagnostic lumbar puncture and myelography. The difference in incidence of headache after diagnostic lumbar puncture and myelography compared with spinal anesthesia were 27.9% (95% CI: 18.6 to 37.2) and 18.3% (95% CI: 9.1 to 27.5).
The flow characteristics of four different types of spinal needles were investigated by measuring the infusion pressure during steady state infusion of either saline or an X-ray contrast agent (76). Two pencil point needles, a Whitacre 22Gauge and a Sprotte 24Gauge, possessed flow characteristics similar to a 22Gauge Quincke point needle. Use of pencil point needles for spinal anesthesia results in a lower incidence of postdural puncture headache compared to the Quincke point needle.
A randomized study was carried out on 160 patients aged 30-60 years with the aim of finding a method of preventing postdural puncture headache (PDPH) (77). In
Needle gauge and tip
Buettner et al. (78) evaluated the influence of the shape of the needle tip on postdural puncture headache (PDPH) independent of the needle diameter, a 25-gauge Whitacre and a 25-gauge Quincke needle were compared. In a prospective, randomized, double-blind fashion, the study was carried out on 400 patients who received spinal anesthesia for operations of the lower extremities. The 25-gauge Whitacre needle (group 1) and the 25-gauge Quincke needle (group 2) were randomly assigned to the patients, 200 in each group. Patients were interviewed postoperatively on days 1, 3, 5, and 7 using a standardized questionnaire. Only postural headache was defined as PDPH. The intensity of both postural and nonpostural headache were quantified using a 4-point rating scale and a visual analog pain scale (VAS). Statistical analysis was performed with parametric and nonparametric tests when appropriate, p < or = 0.05 was considered as significant. There were no differences in age and sex distribution between the two groups. Significantly more patients in group 2 (8.5%) complained of PDPH than in group 1 (3%, p < or = 0.02). Duration of PDPH ranged from 1-3 days (median: 1) in group 1, and from 1-9 days (median: 3) in group 2. This difference closely approached significance (p = 0.058). The mean maximal intensity of PDPH was comparable in both groups. Severe PDPH occurred only in two patients of group 2. One of them required a blood patch. With respect to the nonpostural headache, no significant differences were seen. The use of a conical tipped Whitacre needle results in significantly less PDPH compared to a standard Quincke spinal needle of the same size.
Small-gauge needles are reported to have a low incidence of complications. Pencil-point needles are associated with a lower frequency of postdural puncture headache (PDPH), but a higher failure rate than Quincke needles. The incidence of PDPH was investigated in 200 patients under the age of 45, undergoing day-care surgery, after spinal anesthesia with either 27-gauge Quincke or Whitacre needle (79). The severity of headache was graded as I (mild), II (moderate) or III (severe) using a grading system based on the visual analogue scale (VAS) associated with a functional rating (FG). The frequency of PDPH following the Whitacre needle was 0% and 5.6% after the Quincke needle (P = 0.05). Two PDPHs were assessed as grade III, and three as grade II. All PDPHs occurred when the Quincke needle bevel was withdrawn perpendicular to the dural fibres following parallel insertion. No PDPH occurred when the bevel was inserted and removed parallel to the dural fibres (P < 0.05). There was no statistical difference (P > 0.08) in the incidence of PDPH and postdural puncture-related headaches (PDPR-H) in patients with recurrent headaches or migraine compared to patients with no previous history of headaches.
Lambert et al. (80) evaluated the role of needle diameter and tip configuration in causing PDPH. The incidence of PDPH after spinal anesthesia with 26- and 27-gauge Quincke and 25-gauge Whitacre needles was studied in a series of 4,125 parturients undergoing spinal anesthesia over a 4-year period. Data were also collected on the incidence of PDPH with 17-gauge Huber-tipped Weiss needles in 21,578 parturients receiving lumbar epidural analgesia and/or anesthesia over the same interval. Additionally, the need to treat PDPH with epidural blood patch in all of these patients was studied. The incidence of PDPH was 5.2% with 26-gauge Quincke needles (1987-1989), 2.7% with 27-gauge Quincke needles (1989-1990), and 1.2% with 25-gauge Whitacre needles (1990-1991). During the same periods, the incidence of PDPH with 17-gauge Weiss needles averaged 1.1%, 1.7% and 1.2%, respectively. As compared with the 26-gauge Quincke needle, there was a lower incidence of PDPH with the 27-gauge Quincke (P < .006) and 25-gauge Whitacre spinal needles (P < .001). The incidence of PDPH with the 25-gauge Whitacre needle was less than that with the 27-gauge Quincke needle (P < .05), and it was similar to the overall rate of headache, which occurs occasionally from accidental dural puncture during the performance of lumbar epidural analgesia/anesthesia for labor and cesarean delivery (P = .974). The need for treating PDPH with epidural blood patching was greatest with the 17-gauge Weiss epidural needle (75.3% of cases), but was similar with the various spinal needles (13-39%). However, because the Whitacre needle produced the fewest PDPHs, it was associated with the lowest absolute requirement for epidural blood patching.
Fernandez et al. (81) compared two 27-gauge anesthesia needles with different points (a Whitacre-type point and a Quincke-type point) and assessed the incidences of postdural puncture headache (PDPH), puncture difficulty and failed anesthesia. This prospective, randomized and double-blind trial enrolled 1,555 patients receiving spinal anesthesia for lower abdominal surgery. No age limits were established. A 27-gauge Whitacre-point needle was used in group I (n = 748) and a 27-gauge Quincke-point needle was used in group II (n = 774). The incidences of PDPH were significantly different in groups I (0.53%) and II (1.85%) (p < 0.01). Puncture was easy in 84.89% of the procedures in group I and in 78.81% in group II (p < 0.01). The number of cases in which a puncture could not be accomplished was similar in the two groups (2.41% in group I and 2.07% in group II). The number of failed anesthetic procedures was also similar (0.96% in group I and 1.45% in group II).
Campbell et al. (83) in a prospective, randomized, double-blind study compared the incidence of PDPH and ease of insertion of the 24G Sprotte and the 25G Whitacre needles in 304 ASA 1 and 2 women having elective Cesarean section under spinal anesthesia. Each patient was assessed daily for five consecutive days following Cesarean section by an investigator blinded to the needle used. The results indicate that the two needles have a similar ease of insertion, number of failed insertions, and failed subarachnoid blockade. An inability to insert the spinal needles occurred in two patients in each group. Therefore, 150 patients in each group completed the study. The incidence of PDPH with the 24G Sprotte needle was 4.0% (6/150) compared with 0.66% (1/150) with the 25G Whitacre (NS). There was no correlation between the occurrence of PDPH and the difficulty of needle insertion, presence of transient hypotension or the effectiveness of anesthesia delivered. This study indicates that both needles are comparable with respect to ease of insertion and incidence of PDPH. As the Whitacre needle is less expensive it is a reasonable alternative to the more expensive Sprotte needle.
Mayer et al. (84) conducted a study with the 24-gauge Sprotte and 27-gauge Quincke needles in patients undergoing elective and emergency cesarean section (n = 298). The needle to be used was assigned in a random manner: group I, 27-gauge Quincke (n = 147); group II, 24-gauge Sprotte (n = 151). During the postoperative period, patients were visited daily and asked specifically about the presence and severity of headache. The overall incidence of PDPH was 2% (n = 6), five in the Quincke group (3.5%) and one in the Sprotte group (0.7%). There was no significant difference in the incidence of PDPH between the two groups. Five headaches were classified as mild, and only one was moderate to severe. All headaches resolved quickly with conservative management and without blood patch.
Two thousand three hundred and seventy-eight spinal anesthetics using a 29 G Quincke point needle were administered in a
Post-dural puncture headache (PDPH) is a significant complication of spinal anesthesia. Diameter and tip of the needle as well as the patient's age have been proven to be important determinants. The question of whether post-operative recumbency can reduce the risk of PDPH has not been answered uniformly. And besides, some studies referring to this subject reveal methodical failures, for example, as to clear definition and exact documentation of post-operative immobilization. Furthermore, fine-gauge needles (26G or more) have not been investigated yet. The first aim of the study of Hafer et al. (86) was therefore to examine the role of recumbency in the prevention of PDPH under controlled conditions using thin needles. Secondly, they wanted to confirm the reported prophylactic effect of needles with a modified, atraumatic tip (Whitacre and Atraucan) by comparing them to Quincke needles of identical diameter. Most of the former investigators compared Quincke with atraumatic needles of different size regardless of the known influence of the diameter on PDPH. In a prospective study they included 481 consecutive patients undergoing a total of 500 orthopedic operations under spinal anesthesia. The latter was performed in a standardized manner (patient sitting, midline approach, needle with parallel bevel direction), using four different needles allocated randomly (26-gauge and 27-gauge needles with Quincke tip, 26-gauge Atraucan and 27-gauge Whitacre cannula). Half of the patients were instructed to stay in bed for 24 h (horizontal position without raising head), the others to get up as early as possible. An anesthesiologist visited the patients on the fourth postoperative day or later and questioned them about headache and duration of recumbency. Additionally, the patients had to fill out a questionnaire 1 week after surgery. Any postural headache was considered as PDPH. The four groups of different needles had homogeneous demographic characteristics. A total of 47 patients (9.4%) developed PDPH. The incidence was highest after puncture with a 26-gauge Quincke cannula (17.6%) with a significant difference compared to the other needles. PDPH incidence correlated well with increasing age and number of dural punctures, but showed no relation to sex, patient's history of headache or experience of the anesthesiologist. Only about half of the patients (60.5%) followed the instructions regarding mobilization or recumbency. The duration of strict bed rest did not influence the development of PDPH: The overall incidence was 9.4% in the recumbency group and 8.8% in the group of early ambulation. In all, 45 patients suffered from ordinary not posture-related headache. The significantly higher incidence of PDPH after spinal anesthesia with 26-gauge Quincke needles compared to the 27-gauge Quincke and the 26-gauge Atraucan group confirmed the importance of both needle diameter and design of its tip. Consequent bed rest, however, was not able to reduce its incidence.
The tips of the bevels of thin spinal needles may be easily damaged by bony contact during puncture attempts. In this respect and also because they are less traumatic by design, noncutting, pencil-point-tip needles may be beneficial. A prospective clinical comparison of postanesthetic effects of the use of 27G Quincke-type and pencil-point spinal needles was performed by Puolakka et al. (87). The study included 400 spinal anesthesia patients, in 200 of whom the initial needle was a 27-gauge Quincke type, a 27-gauge pencil-point needle being used in the other 200. Altogether, 464 needles had to be used; in 30 cases the pencil-point needle was replaced by a 27- or 25-gauge Quincke-type needle. A block performance form was filled in, and the patients were interviewed personally on the first postoperative day and by means of a mailed questionnaire on the 14th day. The tips of the Quincke-type needles were distorted in a blunt, bent or hooked manner in 13% of the initial and 14% of the final needles. The severity of the damage was related to the count category of bony contacts during puncture (0, 1-4, or 5 or more). The occurrence of postdural puncture headache was not, however, related either to damage of the needles or to the number of puncture attempts. Diffuse (not posture-dependent) headache occurred more often after the use of the Quincke-type needle than after use of the pencil-point needles, the tips of which remained intact in each case. Postanesthetic sequelae, including postdural puncture headache (overall incidence 2.5%), were not related to the shape of the spinal needles or to the damage of the Quincke-type needles.
A retrospective study was undertaken in patients who received spinal anesthesia in past two years in order to find out the incidence of post-spinal headache (88). There were 3729 cases, 1997 males and 1732 females. Seventy-two patients were noted to have post-spinal headache of whom twelve were male and sixty were female. The overall incidence was 1.93%. Incidence was 0.6% and 3.5% in male and female groups respectively. With respect to the type of surgical procedures in female group, patients undergoing Cesarean section had a higher incidence than those who received other surgical procedures, being 4.8% and 1.5% respectively.
A randomised study was performed to compare the frequency of postdural puncture headache in 56 patients who underwent spinal anesthesia for extra-corporeal shockwave lithotripsy using either a Sprotte 24 G (n = 28) or Vygon 29 G or Quincke type needle (n = 28) (89). Frequency of headache was recorded in a similar group of 28 patients who received general anaesthesia. Dural puncture was easier with the Sprotte 24 G cannula than with the less stable Quincke needle, as documented by a significantly shortened time for insertion of the cannula (4.6 +/- 2.6 vs 8.6 +/- 6.3 min, P less than 0.005). The total frequency of post-operative headache was 57% in the Vygon 29 G group and 25% in the Sprotte 24 G group; 21% of patients in the general anesthesia group complained of headache. Frequency of postdural puncture headache, classified as being posture-related, was 25% in the 29 G Vygon group, compared with 11% in the 24 G Sprotte group (P = 0.148). When only moderate and severe postdural puncture headache was considered, there was a significant difference (25% vs. 4%; P = 0.026) in favour of the Sprotte cannula.
One hundred elderly male patients undergoing transurethral surgery were allocated randomly to receive spinal anesthesia with either a 26 gauge Yale needle or a 24 gauge Sprotte needle (90). Patients were visited within 48 h by an investigator who was unaware of the needle type used and specific enquiry was made about any headache which was characteristic of dural puncture. There was an evidence of a postdural puncture headache in 15 (30%) patients in whom a 26 gauge Yale needle was used. By comparison, only three patients (6%) in the Sprotte group reported a postdural puncture headache. This represents a highly significant (P < 0.005) reduction in the incidence of postdural puncture headache. The incidence of multiple attempts at dural puncture was also significantly (P < 0.05) reduced to 16% in the Sprotte group compared with 28% in the Yale group.
PDPH is not the privilege of spinal anesthesia, as it can occur in various circumstances including epidural anesthesia, surgical wound of the dura, spinal tap and/or myelography. Diagnosis of PDPH can be discussed with four etiologies: cortical vein thrombosis, meningitis, intracranial hematomas (intracerebral, subdural) or migraine. PDPH results from the leakage of CSF via the dural hole, responsible for hypotension of CSF in the subarachnoid compartment. The incidence of PDPH varies with age, maximum from 15 to 50 years-old, to reach a very low incidence over 65. PDPH seems to occur more frequently in women, especially during pregnancy. The diameter of the spinal needle is the main factor of PDPH. Using small diameters (25 G and less) allows to reduce the percentage of PDPH, as well as using specially designed needles with a "pinpoint bevel" (Sprotte, Whitacre). When PDPH occurs, no specific treatment is required before the fifth day, as it spontaneously resolve in 80% of the patients, without any intervention. Afterwards, epidural blood patch allows 90% success rate. Prevention of PDPH appears to be the keypoint, paying particular attention to the choice of the needle and of the spinal puncture technique (91).
The incidence of postdural puncture headache (PDPH) was studied in in-patients after spinal anesthesia with 25 gauge Polymedic needle (Sprotte-like), for lower segment cesarean section (LSCS) (92). A total of 281 women who underwent LSCS were studied, at the maternity unit of St. Peter's Hospital,
The incidence of postdural puncture headache (PDPH) was investigated prospectively in 873 consecutive patients undergoing a total of 1021 spinal anesthesias, and its association to age, sex, needle size, number of attempted dural punctures, needle bevel direction, duration of postoperative recumbency, and previous PDPH was analyzed (93). Multivariate analysis showed that age (P less than 0.0001), direction of the bevel of the needle when puncturing the dura mater (P = 0.022), and a history of previous PDPH (P = 0.018) were significant predictors of PDPH. The estimated relation between PDPH, on the one hand, and age and orientation of the bevel, on the other, enables the anesthetist to predict the risk of PDPH and thereby to choose an acceptable age limit for spinal anesthesia.
Spinal anesthesia was performed on 101 patients with a 25-Gauge (0.52 mm) needle (94). There was a 13.9% overall incidence of postdural puncture headache (PDPH) in an orthopedic population whose mean age was 33.6 years.
Hopkinson et al. (95) studied 681 patients in a randomised, multicentre, double-blind, parallel group trial designed to assess the incidence of headache following spinal anesthesia for Cesarean section using four different pencil point spinal needles. The needles used were: Whitacre 25G (n = 170), Polymedic 25G (n = 170), Sprotte 24G (n = 173) and Polymedic 24G (n = 168). The incidence of all headaches prior to discharge was 11.1%. Only five headaches (0.75%) were severe with features of post dural puncture headache (PDPH) and required an epidural blood patch: Whitacre 25G = 0, Polymedic 25G = 1 (0.6%), Sprotte 24G = 2 (1.2%), Polymedic 24G = 2 (1.2%). There was no statistically significant difference between the four groups for PDPH.
Liu et al. (96) examined whether leaving an intrathecal catheter in place in the postoperative period prevents postdural puncture headache (PDPH). Lumbar puncture was performed with an 18-gauge Tuohy needle. 0.5% bupivacaine spinal anesthesia was given through a 20-gauge catheter in 87 patients having orthopedic surgery. Postoperatively, patients were allocated randomly to have the catheter immediately withdrawn (group 1, N = 47) or kept in place for 12 to 24 hours (group 2, N = 40). Patients were questioned by a blinded observer, about PDPH twice a day on postoperative days 1, 2, 3, and 8. The incidence of PDPH was 9.2%, and this was comparable in the two groups (5 patients in group 1 and 3 patients in group 2). It was concluded that leaving the intrathecal catheter in place in the postoperative period for 12 to 24 hours does not prevent PDPH.
Aamodt and Vedeler (97) studied the incidence of complications after diagnostic lumbar puncture (LP) related to needle type. A 5 months' observational study of routine diagnostic LP in 83 patients was conducted. Significantly more headache was observed after LP using thicker cutting needles (20G Quincke) compared with thinner cutting or non-cutting needles (22G Quincke or pencil-point). No significant difference in complications after LP was found between the 22G Quincke and pencil-point needles.
Audiograms were performed pre-operatively and 2 days postoperatively in 48 patients given spinal anesthesia for transurethral resection of the prostate (98). Hearing levels were examined at 1000 Hz and below. Either 22 G standard design (Quincke) needles (n = 25) or 22 G pencil-point design (Whitacre) needles (n = 23) were used. Hearing loss of 10 dB or more at two or more frequencies were observed in six of 25 patients in the Quincke group and in two of 23 patients in the Whitacre group. The mean hearing level was more reduced in the Quincke group. The shape of the tip of the spinal needle seems to be of some importance to the effects on hearing level that may occur after spinal anesthesia.
Jensen et al. (99) in a prospective, randomised study examined 197 patients aged below 40 years who received spinal analgesia using one of the following needles: Sprotte G24, Spinocan G27 or Atraucan G26. The incidence of insufficient or failed analgesia and difficulties handling the needles were noted. Patients were interviewed within three weeks after anesthesia so as to establish the incidence of postoperative complications including post-dural puncture headache (PDPH). Headache was noted in 63 patients of which 33 (16.8%) were of PDPH type. The Sprotte needle caused significantly fewer cases of PDPH (Sprotte: 8.1%; Spinocan: 19.7%; Atraucan: 21.7%. p < 0.05). Furthermore a significantly lower incidence of insufficient analgesia was observed with the Sprotte needle (0% versus 12.1% with the Spinocan and 11.6% with the Atraucan, p < 0.05).
Casati et al. (100) evaluated the influence of needle type on the lateral distribution of 0.5% hyperbaric bupivacaine; 30 patients undergoing lower limb surgery were placed in the lateral position with the side to be operated on dependent and underwent dural puncture by either a 25-gauge Whitacre (n = 15) or a 25-gauge Quincke (n = 15) spinal needle. The needle hole was turned toward the dependent side and 8 mg of 0.5% hyperbaric bupivacaine was injected over 30 s. The lateral position was maintained for 15 min while a blind observer recorded loss of pinprick sensation and degree of motor block on both the dependent and nondependent sides every 5 min until regression of motor block by 1 degree on the dependent side. Thirty minutes after the patients were placed in the supine position, unilateral sensory block was observed in 10 patients in the Whitacre group (66%) and in 2 patients in the Quincke group (13%) (P < 0.05). No differences in the rate of unilateral motor block were observed (73% and 40% in Whitacre and Quincke groups, respectively).
Casagran et al. (101) prospectively studied 270 patients who underwent intradural anesthesia for programmed urologic, traumatologic, general, and gynecologic surgery. The mean age of the patients was 55.6 +/- 16.9 years. There were significant differences between the age of women (54.8 +/- 15.5 years) and men (56.4 +/- 18.4 years). Intradural anesthesia was performed with a Becton-Dickinson 26G needle with a Quincke tip. Patients were randomly divided into two groups according to that puncture was directed parallel (group 1) or perpendicular (group 2) to the dura-mater fibers. When the spinal liquid dripped through the needle, 2 ml of a 0.75% (15 mg) solution of bupivacaine and 0.2 ml of a 50% (100 mg) solution of glucose were injected. No special measures were undertaken during the postoperative phase. The incidence of headache was analyzed 72 hours after puncture. One patient of group 1 (0.66%) and 6 patients of group 2 (5%) presented headache. This difference was not statistically significant. Differences between the incidence of headache in women (4.05%) and in men (2.15%) were also not significant.
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