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BMC Surgery
Published in: BMC Surgery 1/2007

Open Access 01-12-2007 | Study protocol

Investigating the effect of intra-operative infiltration with local anaesthesia on the development of chronic postoperative pain after inguinal hernia repair. A randomized placebo controlled triple blinded and group sequential study design [NCT00484731]

Authors: Philipp Honigmann, Henning Fischer, Anita Kurmann, Laurent Audigé, Guido Schüpfer, Jürg Metzger

Published in: BMC Surgery | Issue 1/2007

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Abstract

Background

Inguinal hernia repair is one of the most frequently performed procedures in Switzerland (15'000/year). The most common complication postoperatively is development of chronic pain in up to 30% of all patients irrespective of the operative technique.

Methods/Design

264 patients scheduled for an inguinal hernia repair using one of three procedures (Lichtenstein, Barwell and TEP = total extraperitoneal hernioplasty) are being randomly allocated intra-operatively into two groups. Group I patients receive a local injection of 20 ml Carbostesin® 0.25% at the end of the operation according to a standardised procedure. Group II patients get a 20 ml placebo (0.9% Saline) injection. We use pre-filled identically looking syringes for blinded injection, i.e. the patient, the surgeon and the examinator who performs the postoperative clinical follow-ups remain unaware of group allocation. The primary outcome of the study is the occurrence of developing chronic pain (defined as persistent pain at 3 months FU) measured by VAS and Pain Matcher® device (Cefar Medical AB, Lund, Sweden).
The study started on July 2006. In addition to a sample size re-evaluation three interim analyses are planned after 120, 180 and 240 patients had finished their 3-months follow-up to allow for early study termination.

Discussion

Using a group sequential study design the minimum number of patients are enrolled to reach a valid conclusion before the end of the study.
To limit subjectivity, both a VAS and the Pain Matcher® device are used for the evaluation of pain. This allows us also to compare these two methods and further assess the use of Pain Matcher® in clinical routine.
The occurrence of chronic pain after inguinal hernia repair has been in focus of several clinical studies but the reduction of it has been rarely investigated. We hope to significantly reduce the occurrence of this complication with our investigated intervention.

Trial Registration

Our trial has been registered at ClinicalTrials.gov. The trial registration number is: [NCT00484731].
Appendix
Available only for authorised users
Literature
1.
Metzger J: [Meshes for inguinal hernia repair]. Schweiz Rundsch Med Prax. 2003, 92 (40): 1683-1685.
2.
Nienhuijs SW, van Oort I, Keemers-Gels ME, Strobbe LJ, Rosman C: Randomized trial comparing the Prolene Hernia System, mesh plug repair and Lichtenstein method for open inguinal hernia repair. Br J Surg. 2005, 92 (1): 33-38. 10.1002/bjs.4702.CrossRefPubMed
3.
Callesen T, Bech K, Kehlet H: Prospective study of chronic pain after groin hernia repair. Br J Surg. 1999, 86 (12): 1528-1531. 10.1046/j.1365-2168.1999.01320.x.CrossRefPubMed
4.
Poobalan AS, Bruce J, King PM, Chambers WA, Krukowski ZH, Smith WC: Chronic pain and quality of life following open inguinal hernia repair. Br J Surg. 2001, 88 (8): 1122-1126. 10.1046/j.0007-1323.2001.01828.x.CrossRefPubMed
5.
Poobalan AS, Bruce J, Smith WC, King PM, Krukowski ZH, Chambers WA: A review of chronic pain after inguinal herniorrhaphy. Clin J Pain. 2003, 19 (1): 48-54. 10.1097/00002508-200301000-00006.CrossRefPubMed
6.
Page B, Paterson C, Young D, O'Dwyer PJ: Pain from primary inguinal hernia and the effect of repair on pain. Br J Surg. 2002, 89 (10): 1315-1318. 10.1046/j.1365-2168.2002.02186.x.CrossRefPubMed
7.
Bay-Nielsen M, Nilsson E, Nordin P, Kehlet H: Chronic pain after open mesh and sutured repair of indirect inguinal hernia in young males. Br J Surg. 2004, 91 (10): 1372-1376. 10.1002/bjs.4502.CrossRefPubMed
8.
Courtney CA, Duffy K, Serpell MG, O'Dwyer PJ: Outcome of patients with severe chronic pain following repair of groin hernia. Br J Surg. 2002, 89 (10): 1310-1314. 10.1046/j.1365-2168.2002.02206.x.CrossRefPubMed
9.
Mui WL, Ng CS, Fung TM, Cheung FK, Wong CM, Ma TH, Bn MY, Ng EK: Prophylactic ilioinguinal neurectomy in open inguinal hernia repair: a double-blind randomized controlled trial. Ann Surg. 2006, 244 (1): 27-33. 10.1097/01.sla.0000217691.81562.7e.CrossRefPubMed
10.
Ravichandran D, Kalambe BG, Pain JA: Pilot randomized controlled study of preservation or division of ilioinguinal nerve in open mesh repair of inguinal hernia. Br J Surg. 2000, 87 (9): 1166-1167. 10.1046/j.1365-2168.2000.01529.x.CrossRefPubMed
11.
Lundeberg T, Lund I, Dahlin L, Borg E, Gustafsson C, Sandin L, Rosen A, Kowalski J, Eriksson SV: Reliability and responsiveness of three different pain assessments. J Rehabil Med. 2001, 33 (6): 279-283. 10.1080/165019701753236473.CrossRefPubMed
12.
DeLoach LJ, Higgins MS, Caplan AB, Stiff JL: The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998, 86 (1): 102-106. 10.1097/00000539-199801000-00020.PubMed
13.
Stener-Victorin E, Kowalski J, Lundeberg T: A new highlyreliable instrument for the assessment of pre- and postoperative gynecological pain. Anesth Analg. 2002, 95 (1): 151-157. 10.1097/00000539-200207000-00027. table of contentsCrossRefPubMed
14.
Stener-Victorin E, Lundeberg T, Kowalski J, Opdal L, Sjostrom J, Lundeberg L: Perceptual matching for assessment of itch; reliability and responsiveness analyzed by a rank-invariant statistical method. J Invest Dermatol. 2003, 121 (6): 1301-1305. 10.1046/j.1523-1747.2003.12622.x.CrossRefPubMed
15.
Jedel E, Carlsson J, Stener-Victorin E: Health-related quality of life in child patients with temporomandibular disorder pain. Eur J Pain. 2006
16.
Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C: Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006, 79 (4): 371-378. 10.1016/j.clpt.2005.12.307.CrossRefPubMed
17.
O'Dwyer PJ, Serpell MG, Millar K, Paterson C, Young D, Hair A, Courtney CA, Horgan P, Kumar S, Walker A: Local or general anesthesia for open hernia repair: a randomized trial. Ann Surg. 2003, 237 (4): 574-579. 10.1097/00000658-200304000-00020.CrossRefPubMedPubMedCentral
18.
Dierking GW, Ostergaard E, Ostergard HT, Dahl JB: The effects of wound infiltration with bupivacaine versus saline on postoperative pain and opioid requirements after herniorrhaphy. Acta Anaesthesiol Scand. 1994, 38 (3): 289-292.CrossRefPubMed
19.
LeBlanc KA, Bellanger D, Rhynes VK, Hausmann M: Evaluation of continuous infusion of 0.5% bupivacaine by elastomeric pump for postoperative pain management after open inguinal hernia repair. J Am Coll Surg. 2005, 200 (2): 198-202. 10.1016/j.jamcollsurg.2004.10.011.CrossRefPubMed
20.
Ausems ME, Hulsewe KW, Hooymans PM, Hoofwijk AG: Postoperative analgesia requirements at home after inguinal hernia repair: effects of wound infiltration on postoperative pain. Anaesthesia. 2007, 62 (4): 325-331. 10.1111/j.1365-2044.2007.04991.x.CrossRefPubMed
21.
Aasvang E, Kehlet H: Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005, 95 (1): 69-76. 10.1093/bja/aei019.CrossRefPubMed
22.
Lichtenstein IL, Shulman AG, Amid PK, Montllor MM: The tension-free hernioplasty. Am J Surg. 1989, 157 (2): 188-193. 10.1016/0002-9610(89)90526-6.CrossRefPubMed
23.
Amid PK, Lichtenstein IL: The Lichtenstein open "tension-free"mesh repair of inguinal hernias. Rozhl Chir. 1995, 74 (6): 296-301.PubMed
24.
Striffeler H, Zufferey S, Schweizer W: [Quality control after introduction of a new hernia technique. Barwell transversal fascia-plasty]. Helv Chir Acta. 1993, 59 (5–6): 771-774.PubMed
25.
Corbitt JD: Laparoscopic herniorrhaphy. A preperitoneal tension-free approach. Surg Endosc. 1993, 7 (6): 550-555. 10.1007/BF00316702.CrossRefPubMed
26.
O'Brien PC, Fleming TR: A multiple testing procedure for clinical trials. Biometrics. 1979, 35 (3): 549-556. 10.2307/2530245.CrossRefPubMed
27.
O'Brien PC, Shampo MA: Statistical considerations for performing multiple tests in a single experiment. 1. Introduction. Mayo Clin Proc. 1988, 63 (8): 813-815.CrossRefPubMed
28.
O'Brien PC, Shampo MA: Statistical considerations for performing multiple tests in a single experiment. 2. Comparisons among several therapies. Mayo Clin Proc. 1988, 63 (8): 816-820.CrossRefPubMed
29.
O'Brien PC, Shampo MA: Statistical considerations for performing multiple tests in a single experiment. 3. Repeated measures over time. Mayo Clin Proc. 1988, 63 (9): 918-920.CrossRefPubMed
30.
O'Brien PC, Shampo MA: Statistical considerations for performing multiple tests in a single experiment. 4. Performing multiple statistical tests on the same data. Mayo Clin Proc. 1988, 63 (10): 1043-1045.CrossRefPubMed
31.
O'Brien PC, Shampo MA: Statistical considerations for performing multiple tests in a single experiment. 5. Comparing two therapies with respect to several endpoints. Mayo Clin Proc. 1988, 63 (11): 1140-1143.CrossRefPubMed
32.
O'Brien PC, Shampo MA: Statistical considerations for performing multiple tests in a single experiment. 6. Testing accumulating data repeatedly over time. Mayo Clin Proc. 1988, 63 (12): 1245-1250.CrossRefPubMed
33.
Pocock SJ: Group sequential methods in the design and analysis of clinical trials. Biometrics. 1977, 64: 191-199. 10.1093/biomet/64.2.191.CrossRef
34.
Pocock SJ: Interim analyses for randomized clinical trials: the group sequential approach. Biometrics. 1982, 38 (1): 153-162. 10.2307/2530298.CrossRefPubMed
35.
Fleming TR, Harrington DP, O'Brien PC: Designs for group sequential tests. Control Clin Trials. 1984, 5 (4): 348-361. 10.1016/S0197-2456(84)80014-8.CrossRefPubMed
36.
Wang SK, Tsiatis AA: Approximately optimal one-parameter boundaries for group sequential trials. Biometrics. 1987, 43 (1): 193-199. 10.2307/2531959.CrossRefPubMed
37.
Metadata
Title
Investigating the effect of intra-operative infiltration with local anaesthesia on the development of chronic postoperative pain after inguinal hernia repair. A randomized placebo controlled triple blinded and group sequential study design [NCT00484731]
Authors
Philipp Honigmann
Henning Fischer
Anita Kurmann
Laurent Audigé
Guido Schüpfer
Jürg Metzger
Publication date
01-12-2007
Publisher
BioMed Central
Published in
BMC Surgery / Issue 1/2007
Electronic ISSN: 1471-2482
DOI
https://doi.org/10.1186/1471-2482-7-22

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