Local Anaesthetic Following Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00471692
Recruitment Status : Terminated (Due to high incidence of neurological complication in those with ilioinguinal block)
First Posted : May 10, 2007
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):
Stuart Walker, Royal Hobart Hospital

Brief Summary:

Inguinal hernia repair is a common surgical procedure. The major current debates revolve around laparoscopic hernia repair. The most recent Cochrane review concluded that laparoscopic inguinal hernia repair was associated with less post operative and chronic pain, shorter convalescence and earlier return to work when compared to open repair (McCormack K, Scott NW, Go PM, Ross S, Grant AM. EU hernia trialist collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev 2003; 1(CD001785.). However, laparoscopic repair has not gained wide acceptance. It is more expensive, technically difficult for the inexperienced surgeon, is associated with rare but potentially more hazardous procedure related complications (Lo CH, Trotter D, Grossberg P. Unusual complications of laparoscopic totally extraperitoneal inguinal hernia repair. ANZ journal of Surgery 2005 Oct, 75(10): 917 - 919.) and unlike open repair, requires a general anaesthetic. Critics state that laparoscopic repair is not suitable for all general surgeons and should be restricted to experts. Two prospective studies have shown that a longer laparoscopic learning curve exists when compared to open surgery. Up to 200 laparoscopic procedures are required to achieve a recurrence rate comparable to open mesh repair. (Bittner R, Schmedt CG, Schwarz J, Kraft K, Leigl BJ. Laparoscopic transperitoneal procedure for routine repair of groin hernia British journal of Surgery 2002 89; 1062 - 1066.) A meta-analysis and large multicentre randomised study have added to these concerns by demonstrating a higher recurrence rate with laparoscopic repair. (Memon MA, Cooper NJ, Memon B, Memon MI, Abrams KR. Meta-analysis of randomised controlled trials comparing open and laparoscopic inguinal hernia repair. British journal of Surgery 2003; 90: 1479 - 1492. Neumayer L, Giobbie-Hurder, Jonasson O, Fitzgibbons R, Dunlop D, Gibbs J et al. Open mesh versus laparoscopic mesh repair of inguinal hernias. New England Journal of Medicine 2004; 350: 1819 - 1827.). Over the period 1998 to 2003, in Denmark, the frequency of laparoscopic repair remained constant at 4.5 - 8.0%, the laparoscopic approach being used more frequently for bilateral hernia repairs and recurrent hernia repairs. There was a higher re-operation rate following laparoscopic repair of bilateral inguinal hernias compared to bilateral open hernia repair. (Wara P, Bay-Nielsen M, Juul P, bendix J, Kehlet H. Prospective nationwide analysis of laparoscopic versus Lichenstein repair of inguinal hernia. British Journal of Surgery 2005 92(10); 1277 - 1281.)

Given these issues, a considerable number of adult inguinal hernia repairs will continue to be performed using the open technique. There is the opportunity to improve the results of open repair by potentially improving post operative pain and chronic pain. One method may be to perform an ilio inguinal nerve block. However, this procedure can be complicated by femoral nerve palsy, colonic or small bowel puncture and pelvic haematomas (Johr M, Sossai R. Colonic puncture during ilioinguinal nerve block in a child. Anesth Analg 1999 88 1051 - 1052, Amory C, mariscal A, Guyot E et al. Is ilioinguinal/iliohypogastric nerve block always totally safe in children? Paediatr Anaesth 2003; 13: 164 - 166. Vaisman J. Pelvic hematoma after an ilioinguinal nerve block for orchialgia Anesth Analg 2001 92 1048 - 1049. Notaras MJ. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve blockade for inguinal herniorrhaphy. British Journal of Surgery 1995 82: 854. Rosario DJ, Skinner PP, Raftery AT. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve blockade for inguinal herniorrhaphy. British journal of Surgery 1994 81: 897. Ghani KR, McMillan R, Paterson-Brown S. Transient femoral nerve palsy following ilio-inguinal nerve blockade for day case inguinal hernia repair. J R Coll Surg Edinb 2002; 47: 626 - 629. Erez I, Buchumensky V, Shenhman Z, et al. Quadriceps paresis in pediatric groin surgery. Pediatr Surg Int 2002; 18: 157 - 158, Vironen J, Neiminen J, Eklund A, Paavolainen P. Randomised clinical trial of Lichtenstein patch or prolene hernia system for inguinal hernia repair. British Journal of Surgery 2006; 93: 33 - 39)), resulting in delayed discharge of patients. It also has a failure rate of 20 - 30% (Lim SL, Ng SB, Tan GM. Ilioinguinal and iliohypogastric nerve block revisited; single shot versus double shot technique for hernia repair in children. Paediatr Anaesth 2002; 12; 255 - 260.) The aim of our study is therefore to assess the role of ilio inguinal nerve block in adult patients undergoing primary inguinal hernia repair.

Condition or disease Intervention/treatment Phase
Inguinal Hernias Drug: Ropivicaine Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo Controlled Study to Compare Ilio Inguinal Nerve Block and Local Wound Irrigation
Study Start Date : October 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Placebo Comparator: placebo
Normal saline placebo
Drug: Ropivicaine
Active Comparator: Ropivocaine
Ilioinguinal nerve block with ropivocaine
Drug: Ropivicaine

Primary Outcome Measures :
  1. Post operative analgesia requirements. Visual analogue scores. [ Time Frame: Hourly following surgery ]

Secondary Outcome Measures :
  1. Return to normal activities. [ Time Frame: 4 weeks post operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Primary unilateral inguinal hernia
  • Aged 18 years or more

Exclusion criteria:

  • Bilateral inguinal hernia repairs to be performed at the same procedure.
  • Recurrent inguinal hernia
  • Patient unable to give informed consent
  • Contraindication to the use of local anaesthetic
  • Operation to be performed under local or spinal anaesthetic.
  • Contraindication to use of diclofenac, fentanyl or paracetamol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00471692

Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7001
Sponsors and Collaborators
Royal Hobart Hospital
Principal Investigator: Stuart walker Royal Hobart Hospital

Responsible Party: Stuart Walker, Staff Specialist, Royal Hobart Hospital Identifier: NCT00471692     History of Changes
Other Study ID Numbers: H0008762
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal