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NCT01090882

Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial

Completed NA Last updated 17 June 2024
What this trial tests

NA trial testing Bupivocaine in Gall Stones in 128 participants. Completed in 1 October 2009.

Timeline
1 July 2009
Primary endpoint
1 October 2009
1 October 2009

Quick facts

Lead sponsorUniversity Hospitals Coventry and Warwickshire NHS Trust
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingquadruple
Primary purposetreatment
Enrollment128
Start date1 July 2009
Primary completion1 October 2009
Estimated completion1 October 2009
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Who can join

18 and older, any sex, with Gall Stones. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash. Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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