Incidence of postdural puncture headache and backache, and success rate of dural puncture: comparison of two spinal needle designs.
Methods: 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.
Results: 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.
Conclusions: 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.
Key Words: anesthesia, lumbar puncture, myelography, spinal headache
Postdural puncture headache (PDPH) is a common complication after dural puncture procedures such as spinal anesthesia, myelograms, and diagnostic lumbar punctures. The risks are especially high in young women during the peripartum period. The incidence of PDPH is affected by factors such as age, gender, spinal needle size, spinal bevel design, and orientation. Ross et al (1) and Cesarini et al (2) reported incidences of spinal headache from 9 to 14.5% after dural puncture with the 25-gauge beveled spinal needle. Carbaat and van Crevel (3) reported a 38% incidence of spinal headache after diagnostic lumbar puncture with an 18-gauge spinal needle. The Atraucan spinal needle is a relatively new needle design. It has dual bevels designed to make a smaller linear cut in the dura mater with the small bevel at the tip while dilating the opening with the other blunt bevel. In vitro, Atraucan spinal needles have been shown to cause less cerebrospinal fluid (CSF) leakage than comparable Quincke (beveled tip), Sprotte, and Whitacre (pencil-point tip) spinal needles, (4-6) and may have potential clinical advantages over other spinal needles. Pencil-point spinal needles have been reported to have a low incidence of PDPH. (7-12) However, there are few published clinical studies (13-15) comparing the success and complication rates of Atraucan spinal needles to pencil-point spinal needles. Holst et al (4) showed that in vitro CSF leakage after use of 26-gauge Atraucan needle was less than after 25-gauge Sprotte and 26-gauge Whitacre needles. Sharma et al (13) and Andres et al (14) reported that the 26-gauge Atraucan spinal needles were technically easier to use than Whitacre 25-gauge or 27-gauge needles. Sharma et al (13) suggested that further studies are required to better define PDPH and complications from Atraucan needles. The goal of this randomized study was to compare the incidence of PDPH and postdural puncture backache (PDPB), the success rate of dural punctures, and the technical difficulty between 26-gauge Atraucan and 25-gauge Whitacre spinal needles used in women undergoing subarachnoid anesthesia for tubal ligation.
Patients and Methods
After institutional review board approval and informed consent, 215 American Society of Anesthesiology Class I to II postpartum patients presenting for elective postpartum bilateral tubal ligations under spinal anesthesia were enrolled in the study. The patients were randomized by means of a computer-generated random number table into either the Atraucan (AT) group (n = 109) or the Whitacre (WH) group (n = 106).
All patients received 30 mL sodium citrate orally and 1,000 mL intravenous (IV) Ringer lactate solution before initiation of the subarachnoid block. Routine intraoperative monitors included continuous electrocardiography, pulse oximetry, and noninvasive arterial blood pressure monitoring.
In the AT group, 26-gauge Atraucan spinal needles (B. Braun Medical, Bethlehem, PA) (outside diameter, 0.45 mm; length, 8.89 cm) were used with the bevel of the needles turned parallel to the longitudinal axis
of the patient's vertebral column. In the WH group, 25-gauge Whitacre spinal needles (Becton-Dickinson, Rutherford, NJ) (outside diameter, 0.5 mm; length, 8.89 cm) were used with the terminal orifice of the needle facing cephalad to the patient. In both groups, a midline lumbar puncture was performed at the L2-3, L3-4, or L4-5 intervertebral space with the patient in the sitting position.
The subarachnoid space was identified and confirmed by return of clear CSF freely to the hub of the spinal needle and a positive aspiration of CSF with a syringe. All patients received a standard spinal anesthetic consisting of 75 mg of 5% lidocaine in 7.5% dextrose injected intrathecally over 10 to 15 seconds. Patients were laid supine immediately after the removal of the spinal needle. An adequate sensory dermatomal blockade level of T4-6 was confirmed before surgical incision. The following data were recorded intraoperatively by an investigator blinded to the type of needle used: 1) the number of attempts before successful identification of the subarachnoid space, 2) final sensory level of the spinal blockade, 3) incidence of failure to obtain CSF, 4) failure of spinal block, 5) time for placement of spinal anesthesia, and 6) amount of intraoperative analgesic supplement required. Failed spinal blockade was defined as inadequate spinal blockade requiring general anesthesia for completion of surgery. Demographics (age; weight; height; parity; history of headache or PDPH; and smoking, caffeine, and alcohol history) were obtained and compared between the two groups.
Postoperatively, an investigator who was blinded to the group assignment interviewed the patients daily while in the hospital and then 7 to 14 days after discharge from the hospital by means of telephone. Patients were questioned for the presence, severity, onset, duration, and characteristics of headaches, backaches, and any other accompanying complaints. As a measure of patient satisfaction, patients were asked whether they would accept similar spinal anesthesia for future surgical procedures.
A PDPH was defined as an occipital or frontal headache brought on by erect posture and relieved when the supine posture was assumed, provided no other cause of headache could be identified. A PDPB was defined as continuous pain localized around the site of spinal needle insertion. The severity, location, and duration of the headache and backache were recorded. The severity of the headache and backache was graded from none to mild, moderate, or severe. Mild PDPH was defined when PDPH caused no interference with daily activities and was treated with no medication or oral analgesics. Moderate PDPH was defined when PDPH caused a patient difficulty in performing daily activities and was treated with oral analgesics. Severe PDPH was defined as a headache that resulted in the patients being unable to perform his or her daily activities or being confined to bed and requiring oral or IV analgesic and/or epidural blood patch for treatment. Mild to moderate PDPH was initially treated conservatively with bed rest, hydration, and oral analgesics. If PDPH was severe or if moderate PDPH did not improve after 24 hours of conservative treatment, an epidural blood patch was offered as the treatment of choice to patients.
At the time we designed our study, we assumed a PDPH rate of 1% for pencil-point spinal needles and 8% for beveled spinal needles from previous reports of pencil-point and beveled spinal needles. A power analysis performed before the study revealed an estimated sample size of 100 per group would be required to give an [alpha] of 0.05 and a power of 0.8. Results were expressed as mean [+ or -] 1 SD or number (%). Interval data were analyzed by analysis of variance and nominal data by using a [chi square] test and Fisher exact test. A value of P < 0.05 was considered significant between the groups.
Two hundred fifteen patients were enrolled. Eleven patients were excluded from the study because of loss in follow-up, cancellation of surgery, or inability to identify the subarachnoid space. The subarachnoid space could not be identified in two patients in the WH group and in one patient in the AT group. After these exclusions, 104 patients remained in the AT group and 100 patients in the WH group. The two groups were demographically similar (Table 1). Anesthesiology residents or senior nurse anesthetist students with close supervision of attending anesthesiologists performed the spinal anesthetic procedures. The distribution in the level of training in the personnel performing the spinal procedures was similar between the two needle groups.
The characteristics of the spinal blockade are summarized in Table 2. The incidences of failed spinal blockade after successful identification of CSF were similar between the AT group (7.7%) and the WH group (7.0%). The percentage of those who received supplemental analgesics were 11 (10.6%) of 104 in the AT group versus 4 (4.0%) of 100 in the WH group. Both groups had similar one-attempt success rates and a similar average number of attempts to obtain CSF; 95% of the AT group and 93% of the WH group would accept similar spinal anesthesia for future procedures.
The incidence, duration, and severity of the complications are summarized in Table 3. The incidences of PDPH and PDPB were similar in both groups. The total number of days that PDPH was experienced among all patients in the AT group was 5 days, whereas in the WH group patients it was 15 days. In the AT group, three patients rated the PDPH as mild and one patient rated the PDPH as moderate. In the WH group, one patient rated the PDPH as mild, two rated it as moderate, and one rated it as severe. No patients received an epidural blood patch (EBP) in this study. The one patient in the WH group who experienced a severe PDPH was offered an EBP, but she refused. The number of patients who experienced a headache (non-PDPH) not believed to be spinal in origin was similar between groups (6 of 100 in the WH group versus 2 of 104 in the AT group). All of the backaches were mild and usually consisted of local tenderness at the site of spinal needle placement. All non-PDPH and backache resolved by itself or with oral anti-inflammatory drugs.
This study showed that the complication rate (PDPH and PDPB) after dural punctures, the success rate of spinal anesthesia, and the ease of successful spinal needle insertion (number of attempts) were similar between Atraucan 26-gauge and Whitacre 25-gauge spinal needles. Both groups had a similar one-attempt success rate and average number of attempts to obtain CSF. Sharma et al (13) and Scott et al (5) had found a similar one-attempt success rate and a high CSF flow rate with the Atraucan spinal needle. Vallejo et al (15) did not report on the one-attempt success rate or technical difficulty associated with needle placement among the five types of spinal needles they studied. We did not measure the tensile strength of the needles in this study, but our investigators experienced subjectively more bending with the Atraucan needle than with the Whitacre needle when the needle encountered calcified ligament or bone during insertion. However, these differences between the Atraucan and Whitacre needles did not affect the clinical outcomes (complications and success rate) we measured in this study. The high flow rate (5,13) and the high one-attempt success rate with the Atraucan needle were probably a result of the larger ejection port design in the 26-gauge Atraucan spinal needle. Shutt et al (8) also reported that more patients experienced paresthesia during needle insertion with the Whitacre (15%) than with the Atraucan needle (2%).
In our study, the incidence of PDPH for both the Atraucan and Whitacre spinal needles was similar to that reported in other studies. (13-16) Even though our data suggest that the quality of PDPH might be different between the two groups, there was no statistically significant difference between the two groups. The incidence of all headaches (PDPH and non-PDPH combined) and non-PDPHs alone trended higher in the WH group, but it was not statistically significant. The EBP rate and the severity of PDPH that our study reported were similar to those reported by Sharma et al (13) and Andres et al. (14)
The 3.9% incidence of PDPH in the AT group in this study was higher than the 2.5% rate reported by Scott et al (5) or the 2.6% rate reported by Schultz et al, (16) and lower than the 5% reported by Vallejo et al. (15) In the study by Scott et al, (5) the data were obtained from six centers in five different countries and included both male and female subjects ranging in age from 15 to 55 years. In the study by Schultz et al, (16) both men and nonpregnant women were included. Because age, gender, pregnancy, type of surgical procedure, history of PDPH, needle diameter, needle tip design, and bevel orientation have all been shown to affect PDPH rates, the small difference in headache rates reported by these studies can probably be explained by the differences in these variables among studies. (17-20)
Postoperative backache is a common complaint after spinal anesthesia. Factors involved in the pathogenesis of postoperative back pain include the type and duration of surgery, duration of immobilization, and the position of the patient during spinal puncture. (21) Several authors had reported the incidence of PDPB, ranging from 5.91% (16) to 22% (13) for the Atraucan needle. In our study, the incidence of PDPB for both spinal needles was in the lower range of those reported in the literature. This may be, in part, because of the short duration of immobilization in our patients. As previously reported with Sprotte and Quincke needles, (11) our data support the viewpoint that PDPB does not seem to be related to differences in the size or shape of the two types of spinal needles studied. In contrast to a previous report, (8) our data do not support the association between the incidence of PDPB and the number of attempts to successfully obtain CSF.
We found that the 26-gauge Atraucan and the 25-gauge Whitacre spinal needles had a similarly high one-attempt success rate of dural puncture, obtaining CSF, and successful spinal blockade. The incidence of PDPH and PDPB was low and was not significantly different between the two types of needles. The low complication and failure rates make these two types of smaller size spinal needle designs good candidates for dural puncture procedures such as spinal anesthesia, diagnostic lumbar punctures, and myelograms.
This country will not be a good place for any of us to live in unless we make it a good place for all of us to live in. --Theodore Roosevelt Table 1. Demographics of patients in the AT and WH groups (a) 26-Gauge AT 25-Gauge WH Characteristic group (n = 104) group (n = 100) Age (y) 28 [+ or -] 5 28 [+ or -] 5 Weight (kg) 76 [+ or -] 14 78 [+ or -] 18 Height (cm) 164 [+ or -] 6 162 [+ or -] 8 Smoking history 36/104 (35%) 41/100 (41%) Frequent caffeine use 74/104 (71%) 73/100 (73%) (a) AT, Atravcan; WH, Whitacre. No statistical difference between groups in all demographic variables. Table 2. Spinal block characteristics between AT and WH groups (a) 26-Gauge AT 25-Gauge WH group (n = 104) group (n = 100) Success with one attempt 64/104 (62%) 61/100 (61%) Range of no. of attempts 1-5 1-6 needed to obtain CSF Average no. of attempts 1.5 [+ or -] 0.6 1.6 [+ or -] 0.7 needed to obtain CSF Patient would accept same 99/104 (95%) 93/100 (93%) spinal technique for future procedures Quality of spinal blockade Adequate 85/104 (82%) 89/100 (89%) Minor supplement 11/104 (10.6%) 4/100 (4.0%) Failed 8/104 (7.7%) 7/100 (7.0%) Unable to identify 1 2 subarachnoid space (a) AT, Atraucan; WH, Whitacre; CSF, cerebrospinal fluid. Differences between the groups are not significant. Table 3. Comparison of complications between AT and WH groups (a) 26-Gauge AT 25-Gauge WH group (n = 104) group (n = 100) Incidence of PDPH Mild 3/104 (2.9%) 1/100 (1.0%) Moderate 1/104 (1.0%) 2/100 (2.0%) Severe 0/104 (0.0%) 1/100 (1.0%) Total 4/104 (3.9%) 4/100 (4.0%) No. of days of PDPH among all patients Mild 4 4 Moderate 1 9 Severe 0 2 Total 5 15 Non-PDPH 2/104 (1.9%) 6/100 (6.0%) All headaches 6/104 (5.8%) 10/100 (10%) combined (PDPH and non-PDPH) Backache 10/104 (9.6%) 9/100 (9.0%) (a) AT, Atraucan; WH, Whitacre; PDPH, postdural puncture headache. Differences between groups are statistically not significant.
Accepted April 30, 2003.
Copyright [c] 2004 by The Southern Medical Association
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RELATED ARTICLE: Key Points
* The incidence of postdural puncture headache and the failure rate of dural punctures using either 26-gauge Atraucan or 25-gauge Whitacre spinal needles were low.
* The low complication and failure rates make these two types of smaller size spinal needle designs good candidates for dural puncture procedures, such as spinal anesthesia, diagnostic lumbar punctures, and myelograms.
Peter H. Pan, MD, MSEE, Regina Fragneto, MD, Charles Moore, PHD, and Vernon Ross, MD
From the Department of Anesthesiology, Wake Forest University, Winston-Salem, NC, the Division of Obstetrical Anesthesia, Department of Anesthesiology, Medical College of Virginia, Virginia Commonwealth University, Richmond, VA, and the Department of Anesthesiology, University of Kentucky College of Medicine, Chandler Medical Center, Lexington, KY.
This study was supported in part by an unrestricted education grant from B. Braun Medical, Inc.
Presented and published in part as an abstract at the Society of Obstetric Anesthesia and Perinatology Annual Meeting, Philadelphia, May 1994; the American Society of Anesthesiology Annual Meeting, Orlando, FL, March 1995; the American Society of Regional Anesthesia annual meeting, San Diego, CA, March 1996; and as an abstract summary in Pan PH, Fragneto R, Moore C, et al. The incidence of failed spinal anesthesia, postdural puncture headache and backache is similar with Atraucan and Whitacre spinal needles. Can J Anaesth 2002;49:636-637 (letter).
Reprint requests to Peter H. Pan, MD, Division of Obstetric Anesthesia, Forsyth Medical Center, 3333 Silas Creek Parkway, Winston-Salem, NC 27103-3090. Email: firstname.lastname@example.org