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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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] 0 0
H0008762
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal Hernias 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ropivicaine

Placebo Comparator: placebo - Normal saline placebo

Active Comparator: Ropivocaine - Ilioinguinal nerve block with ropivocaine


Treatment: Drugs: Ropivicaine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post operative analgesia requirements. Visual analogue scores.
Timepoint [1] 0 0
Hourly following surgery
Secondary outcome [1] 0 0
Return to normal activities.
Timepoint [1] 0 0
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
Terminated
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
12
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 0 0
7001 - Hobart

Funding & Sponsors
Primary sponsor type
Other
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/ct2/show/NCT00471692
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stuart walker
Address 0 0
Royal Hobart Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00471692