Clinical trial

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

Name
UHCW 1
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.
Trial arms
Trial start
2009-07-01
Estimated PCD
2009-10-01
Trial end
2009-10-01
Status
Completed
Treatment
Bupivocaine
20ml 0.25% at beginning of operation
Arms:
Subperitoneal injection, Topical LA
Other names:
marcaine
0.9% normal saline solution
20ml 0.9% NaCl
Arms:
Control
Other names:
marcaine
Size
128
Primary endpoint
VAS pain score
1, 4, 8 hours after operation and at discharge
Eligibility criteria
Inclusion Criteria: * Elective laparoscopic cholecystectomy * 18 years old or over Exclusion Criteria: * Emergency surgery * Under 18 year olds
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 128, 'type': 'ACTUAL'}}
Updated at
2024-06-20

1 organization

2 products

1 indication

Indication
Gallstones