Local Anaesthetic Following Hernia Repair

NCT00471692 | Terminated Phase 1

• 1 other identifier: H0008762
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernias

Outcome Measures

Primary Outcomes (1)

• Post operative analgesia requirements. Visual analogue scores.

  Hourly following surgery

Secondary Outcomes (1)

• Return to normal activities.

  4 weeks post operatively

Study Arms (2)

placebo

PLACEBO COMPARATOR

Normal saline placebo

Drug: Ropivicaine

Ropivocaine

ACTIVE COMPARATOR

Ilioinguinal nerve block with ropivocaine

Drug: Ropivicaine

Interventions

Ropivicaine DRUG

Ropivocaine; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary unilateral inguinal hernia
• Aged 18 years or more

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Hobart Hospital: lead

Study Sites (1)

Royal Hobart Hospital

Hobart, Tasmania, 7001, Australia

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart walker

  Royal Hobart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Specialist

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

AU (1)