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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000785202

Enrollment

100

Registered

2009-09-09

Start date

2009-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results