Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

Study Overview
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Brief Summary
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Laparoscopic cholecystectomy (removal of the gall bladder via 'keyhole surgery') is a common procedure. This can be performed as an emergency operation when a patient has a complication of gall stones such as acute inflammation or pancreatitis. There are several trials which demonstrate that placing local anaesthetic inside the abdomen at the site of gall bladder surgery during a planned elective operation decreases post operative pain. This is the first trial to investigate the efficacy of this local anaesthetic during emergency cholecystectomy.

Detailed Description
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Background Several studies, including a metanalysis, have demonstrated that intraperitoneal local anaesthetic (IP LA) during elective laparoscopic cholecystectomy (el-LC) decreases post operative pain. None have explored the efficacy of IP LA at emergency laparoscopic cholecystectomy (em-LC). A longer operation duration, greater frequency of washing and the inflammation associated with cholecystitis or pancreatitis are a few reasons why it cannot be assumed that a benefit in pain scores will be seen in em-LC with IP LA. This study assesses the efficacy of IP LA used in patients undergoing em-LC. Methods Double blind randomised sham controlled trial of 42 consecutive subjects undergoing em- LC. IP-LA was delivered by a combination of direct injection to the diaphragmatic and topical wash over the liver/gall bladder with bupivacaine or sham depending upon allocation. The primary outcome was VAS pain scores on the ward. Secondary outcomes included VRS pain scores in theatre recovery, analgesic use, physiological observations, time to eating and ambulation and length of postoperative stay. Results One patient had a procedure converted to open and was excluded. There was no significant difference in pain scores on the ward or in theatre recovery. Analgesic use, respiratory rate, oxygen saturation, duration to ambulation, eating, satisfaction scores and time to discharge were comparable between the groups. Conclusions Intraperitoneal LA during em-LC does not influence post-operative pain. Other modalities of analgesia should be explored as well as decreasing the interval between diagnosis of acute admission and em-LC.

Official Title
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Double Blind Sham Controlled Randomised Trial of Intraperitoneal Bupivacaine During Acute Laparoscopic Cholecystectomy

Conditions
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Cholecystitis, Gall Stone Pancreatitis

Intervention / Treatment
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* Drug: Bupivacaine
* Other: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis Exclusion Criteria: patients undergoing planned elective cholecystectomy

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Saline sham injection<br>Sham wash and injection with normal saline (09%) | Other: Normal saline<br>* sodium chloride 0.9% solution<br>|
| Active Comparator: Bupivacaine<br>Bupivacaine injection/wash treatment arm | Drug: Bupivacaine<br>* 0.25% 20ml administered intraperitoneal<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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VRS pain score |  |  | 
| Satisfaction score (VAS) |  |  | 
| Physiological observations - respiratory rate, oxygen saturation |  |  | 
| Analgesic use post operation |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency laparoscopic cholecystectomy, Pain scores, Intraperitoneal local anaesthesia, Cholecystitis