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

Plain Language Summary

Simplified for easier understanding

This study is looking at whether injecting a numbing medicine (local anaesthetic) into a specific area near the abdomen during keyhole (laparoscopic) hernia surgery can reduce pain after the operation. Patients who have hernias in the groin area and are suitable for day surgery will be randomly assigned to receive either the local anaesthetic or a harmless salt-water solution. Researchers will contact participants by phone after surgery to check on their pain levels and any complications. You may be eligible if: - You are between 18 and 80 years old - You have a femoral or inguinal (groin) hernia - Your hernia is suitable for laparoscopic (keyhole) surgical repair - You are fit for day surgery and able to give informed consent You may NOT be eligible if: - You are allergic to marcain (bupivacaine) with adrenaline - Your anaesthetist considers marcain with adrenaline unsuitable for you - You will not be available for follow-up appointments - You are already enrolled in another hernia surgery study at Waitemata District Health Board Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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