Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Gall Stones
• Interventions: Drug: 0.9% normal saline solution; Drug: Bupivocaine

• Registration Number: NCT01090882
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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 Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Elective laparoscopic cholecystectomy
• 18 years old or over

Exclusion Criteria

• Emergency surgery
• Under 18 year olds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control	0.9% normal saline solution	Sham wash, sham injection
Subperitoneal injection	Bupivocaine	Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder
Topical LA	Bupivocaine	Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm

Primary Outcome Measures

Name	Time	Method
VAS pain score	1, 4, 8 hours after operation and at discharge

Secondary Outcome Measures

Name	Time	Method
Time to ambulation	following the procedure	The first time the patient gets out of bed and walks following the procedure
Same day discharge	24 hours
VRS pain scores	Every 10 minutes in theatre recovery	Immediately following the operation

Trial Locations

Locations (1)

UHCW NHS Trust; 🇬🇧 Coventry, Warwickshire, United Kingdom