Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Gall Stones

Intervention / Treatment
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* Drug: Bupivocaine
* Drug: 0.9% normal saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective laparoscopic cholecystectomy 18 years old or over Exclusion Criteria: Emergency surgery Under 18 year olds

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Sham wash, sham injection | Drug: 0.9% normal saline solution<br>* 20ml 0.9% NaCl<br>* Other names: marcaine;|
| Experimental: Subperitoneal injection<br>Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder | Drug: Bupivocaine<br>* 20ml 0.25% at beginning of operation<br>* Other names: marcaine;|
| Active Comparator: Topical LA<br>Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm | Drug: Bupivocaine<br>* 20ml 0.25% at beginning of operation<br>* Other names: marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score |  | 1, 4, 8 hours after operation and at discharge | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local anaesthetic, Laparoscopic cholecystectomy, Pain scores, Bupivocaine, Day case surgery