Clinical Trial: Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial
Brief Summary:
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.
Detailed Summary:
Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Current Primary Outcome: VAS pain score [ Time Frame: 1, 4, 8 hours after operation and at discharge ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to ambulation [ Time Frame: following the procedure ]The first time the patient gets out of bed and walks following the procedure
- Same day discharge [ Time Frame: 24 hours ]
- VRS pain scores [ Time Frame: Every 10 minutes in theatre recovery ]Immediately following the operation
Original Secondary Outcome: Same as current
Information By: University Hospitals Coventry and Warwickshire NHS Trust
Dates:
Date Received: March 18, 2010
Date Started: July 2009
Date Completion:
Last Updated: March 22, 2010
Last Verified: March 2010