Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

University Hospitals Coventry and Warwickshire NHS Trust

Status: Completed

Conditions: Gall Stones

Treatments: Drug: Bupivocaine; Drug: 0.9% normal saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01090882

UHCW 1

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Elective laparoscopic cholecystectomy
• 18 years old or over

Exclusion criteria

• Emergency surgery
• Under 18 year olds

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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128 participants in 3 patient groups

Control

Sham Comparator group

Description:

Sham wash, sham injection

Treatment:

Drug: 0.9% normal saline solution

Subperitoneal injection

Experimental group

Description:

Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder

Treatment:

Drug: Bupivocaine

Topical LA

Active Comparator group

Description:

Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm

Treatment:

Drug: Bupivocaine