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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00471692

Registration number

NCT00471692

Ethics application status

Date submitted

8/05/2007

Date registered

10/05/2007

Date last updated

28/10/2015

Titles & IDs

Public title

Local Anaesthetic Following Hernia Repair

Scientific title

A Randomised, Double Blind, Placebo Controlled Study to Compare Ilio Inguinal Nerve Block and Local Wound Irrigation

Secondary ID [1]

H0008762

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Inguinal Hernias

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Placebo comparator: placebo - Normal saline placebo

Active comparator: Ropivocaine - Ilioinguinal nerve block with ropivocaine

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Post operative analgesia requirements. Visual analogue scores.

Timepoint [1]

Hourly following surgery

Secondary outcome [1]

Return to normal activities.

Timepoint [1]

4 weeks post operatively

Eligibility

Key inclusion criteria

Inclusion criteria:

* Primary unilateral inguinal hernia
* Aged 18 years or more

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment

Single group

Other design features

Phase

Phase 1

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/10/2006

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/11/2009

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Recruitment hospital [1]

Royal Hobart Hospital - Hobart

Recruitment postcode(s) [1]

7001 - Hobart

Funding & Sponsors

Primary sponsor type

Government body

Name

Royal Hobart Hospital

Address

Country

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT00471692

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Stuart walker

Address

Royal Hobart Hospital

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00471692

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00471692