Int J Colorectal Dis (2010) 25:775–781 DOI 10.1007/s00384-010-0888-7
ORIGINAL ARTICLE
High incidence of post-dural puncture headache in patients with spinal saddle block induced with Quincke needles for anorectal surgery: a randomised clinical trial Marc D. Schmittner & Tom Terboven & Michael Dluzak & Andrea Janke & Marc E. Limmer & Christel Weiss & Dieter G. Bussen & Marc A. Burmeister & Grietje C. Beck
Accepted: 8 January 2010 / Published online: 11 February 2010 # Springer-Verlag 2010
Abstract Purpose Spinal saddle block represents nearly the ideal anaesthesia technique for anorectal surgery. Post-dural puncture headache (PDPH) is a dreaded complication but can be decreased by the use of non-cutting spinal needles to rates less than 1%. Though, cutting Quincke type needles are still widely used for economic reasons, leading to a
Marc D. Schmittner and Tom Terboven equally contributed to this work. M. D. Schmittner (*) : T. Terboven : M. Dluzak : A. Janke : M. E. Limmer Department of Anaesthesiology and Surgical Intensive Care Medicine, University Medical Centre Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany e-mail:
[email protected] C. Weiss Department of Medical Statistics, University Medical Centre Mannheim, Mannheim, Germany D. G. Bussen Centre of Colo-Proctology, Mannheim, Germany M. A. Burmeister Department of Anaesthesiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany G. C. Beck Department of Anaesthesiology, Dr. Horst Schmidt Kliniken, Wiesbaden, Germany M. A. Burmeister B. Braun, Melsungen, Germany
higher rate of PDPH. We performed this study to demonstrate a reduction of PDPH by the use of very small 29-G compared with commonly used 25-G Quincke type spinal needles. Methods Two hundred sixteen adult patients (male/female, 19–83 years, ASA status I–III) were randomised 1:1 to groups, in which either a 25-G or a 29-G Quincke type spinal needle was used for a spinal saddle block. The incidence of PDPH was assessed during 1 week after surgery. Results Thirty-nine of 216 patients developed PDPH but there was no difference between the two needle sizes (25-G, n=18/ 106 vs. 29-G, n=21/110, p=0.6870). Women suffered significantly more from PDPH than men (23/86 vs. 16/130, p=0.0069). Ambulatory patients had a later onset of PDPH than in-patients (24 h [0.5–72] vs. 2 h [0.2–96], p=0.0002) and the headache was more severe in these patients (NRS 7 [2–10] vs. NRS 3 [1–8], p=0.0009). Conclusions The use of 29-G compared with 25-G Quincke needles led to no reduction of PDPH and is considerably higher compared with data from pencil-point needles. The use of non-cutting or pencil-point spinal needles should become the standard for performing spinal saddle block. Keywords Anorectal surgery . Anaesthesia . Saddle block . Post-dural puncture headache
Introduction The spinal ‘saddle block’ using low doses of hyperbaric local anaesthetics represents the near to ideal anaesthesia technique for anorectal surgery due to a rapid onset of
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sensory blockade, good intraoperative surgical conditions, as well as a long-lasting post-operative analgesia with a low incidence of complications [1, 2]. This technique is superior to general anaesthesia, concerning analgetics consumption within 24 h after surgery, postoperative recovery, patient satisfaction, as well as economic reasons [3, 4]. Post-dural puncture headache (PDPH) still remains a rare but cumbersome complication of spinal anaesthesia of which the pathomechanism has yet to be completely understood. While atraumatic needles can reduce the incidence of PDPH to less than 1%, cutting needles like the Quincke type needles, are still in use due to assumed economic advantages with a significantly increasing risk for PDPH [5, 6]. Small gauged needles also decrease the risk for PDPH but are technically more challenging to use [6]. Very little information is available about the incidence of PDPH with small Quincke type needles in combination with spinal saddle block [7, 8]. We performed this study to demonstrate a reduction of PDPH by the use of very small 29-G compared with 25-G Quincke type spinal needles, which are assumed cheaper than the non-cutting atraumatic needles, in patients undergoing anorectal surgery under a spinal saddle block.
Materials and methods This prospective, single-centre, randomised, controlled clinical trial was performed according to the guidelines of the Ethic Commission II, Faculty for Clinical Medicine Mannheim, Germany (Vote: 2007-236N-MA, September 19, 2007) and was registered at the International Standard Randomised Controlled Trial Number Register (ISRCTN: 11431649). From March to August 2008, verbal and written information was given to each of the 216 adult patients before informed written consent was obtained. Upon arrival in the operating theatre the patients were randomly allocated 1:1 using sealed envelopes in blocks of 20 to receive a spinal saddle block with either a 25-G or a 29-G Quincke type spinal needle. Study participants were blinded to the type of needle used. Inclusion and exclusion criteria All patients (male/female, 19–83 years; American Society of Anaesthesiologists physical (ASA) status I–III) undergoing in-house and ambulatory anorectal surgery, performed in lithotomy position, were eligible for the study. Exclusion criteria were contraindications against spinal anaesthesia, patients considered to be ASA status IV–I, operation techniques other than in lithotomy position and prior participation in the study.
Int J Colorectal Dis (2010) 25:775–781
Patients and procedures Prior to the scheduled operation, all patients were seen by an anaesthesiologist and were informed verbally and in written form about the study before consenting to participate. Patients were allowed to drink small amounts of clear liquids until 2 h before induction of anaesthesia and received 7.5 mg midazolam (Dormicum, Roche Pharma, Grenzach-Wyhlen, Germany) for oral premedication. Venous cannulation with a 20-G peripheral needle was performed in all patients undergoing the procedure (Liniest Purr, KLINIKA Medical, Singen, Germany), and an infusion with a maximum of 500 mL balanced crystalloid solution (Deltajonin, Delta Select, Dreieich, Germany) was started. ECG, blood pressure and SO2 were measured at 5-min intervals throughout the entire operation. Anaesthesia was performed by M. Schmittner, A. Janke and M. Limmer who have training in anaesthesiology for more than 8 years and are consultant anaesthesiologists in the department. We performed the spinal saddle block under aseptic conditions using a standard midline approach in the sitting position. We injected 1.0 mL hyperbaric bupivacaine 0.5% (Bucain 0.5% hyperbar, Delta Select, Dreieich, Germany) for in-house patients to provide longlasting post-operative analgesia or 0.6 mL hyperbaric mepivacaine 4% (Mecain 4% hyperbar, Delta Select, Dreieich, Germany) for ambulatory patients to achieve fast mobilisation. Depending on randomisation, either a 25-G Quincke needle with introducer (Spinocan 0.53×88 mm− G25×3 1/2, B. Braun, Melsungen, Germany) or a 29-G Quincke needle with introducer (Spinocan 0.35×88 mm− G29×3 1/2, B. Braun, Melsungen, Germany) was inserted into the subarachnoid space at the L3-L4 interspace. We used a vertical bevel direction. All patients remained in the sitting position for exactly 10 min until the anaesthesiologist tested for sensory block before they were transferred to the operation theatre and brought in lithotomy position. Adequate respiration was monitored by measuring oxygen saturation and by semi-quantitative CO2 detection. For post-operative recovery, all patients were monitored until they had reached an Aldrete score [9] of 10 and were ready for transfer to the ward or to the recovery room in case of ambulatory patients. A consultant anaesthesiologist who was blinded towards the needles used and who was not involved in the study assessed the incidence of PDPH according to the symptoms of the International Headache Society via a telephone call (Fig. 1) [10]. Statistics For statistical analysis, the SAS System (release 9.01, SAS Institute Inc., Cary, NC, USA) was used. Quantitative data are
Int J Colorectal Dis (2010) 25:775–781 Fig. 1 Post-dural (post-lumbar) puncture headache [G97.0]. Classification of the International Headache Society (IHS)
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Diagnostic criteria: A. Headache that worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying, with at least one of the following and fulfilling criteria C and D: 1. neck stiffness 2. tinnitus 3. hypacusia 4. photophobia 5. nausea B. Dural puncture has been performed C. Headache develops within 5 days after dural puncture D. Headache resolves either1: 1. spontaneously within 1 week 2. within 48 hours after effective treatment of the spinal fluid leak (usually by epidural blood patch) Note: 1. In 95% of cases this is so. When headache persists, causation is in doubt.
presented as mean values±standard deviation or as median together with range, if the data were skewed or ordinally scaled. Differences between both groups were tested using the two sample t test, chi-square test or the Mann–Whitney U test, as appropriate. Test results were considered statistically significant when the p value was
