RecruitingACTRN12609000785202

Pre-peritoneal local anaesthetic to decrease pain in hernia repairs study

A randomised controlled study evaluating the effectiveness of local anaesthetic into the pre-peritoneal space in controlling post operative pain in laparoscopic inguinal and femoral hernia repairs.


Sponsor

Mr Michael Hulme-Moir

Enrollment

100 participants

Start Date

Sep 1, 2009

Study Type

Interventional

Conditions

Summary

The aims of this study are to assess post operative pain and other surgical complications on elective laparoscopic hernia repair patients following the injection of local anaesthetic into the pre-peritoneal space. This study will enrol patients aged 18 – 80 years of age who are suitable for day surgical repair of their hernias at Waitemata District Health Board and Waitemata Specialist Centre (surgery at Southern Cross Hospital North Harbour). Participants will be randomised to receive 20mls of local anaesthetic or 20mls of normal saline injected into the pre-peritoneal space. They will be followed up by phone at 2 hours after surgery, 1, 7 and 14 days after surgery. They will be seen in the outpatients clinic at 6 weeks after the operation.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

  • Patients with femoral and inguinal hernias that are suitable for laparoscopic surgical repair aged between 18 and 80 years, fit for day surgery and able to consent to the study.

Exclusion Criteria4

  • Patients who have an allergy to marcain with adrenaline
  • Patients with whom the anaesthetist deems marcain with adrenaline is unsuitable.
  • Patients unavailable for follow-up
  • Patients eligible for the Laparoscopic versus Open Inguinal Hernia Repair Study currently recruiting at Waitemata District Health Board

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Interventions

20ml of local anaesthetic (Bupivicaine Hydrochloride 0.25% with adrenaline) vs Placebo (0.9% Sodium Chloride) injected into the pre-peritoneal space during the surgery.

20ml of local anaesthetic (Bupivicaine Hydrochloride 0.25% with adrenaline) vs Placebo (0.9% Sodium Chloride) injected into the pre-peritoneal space during the surgery.


Locations(1)

Auckland, New Zealand

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ACTRN12609000785202