Gall Stones Clinical Trial
Official title:
Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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