Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

Not Applicable

Completed

• Conditions: Cholecystitis; Gall Stone Pancreatitis
• Interventions: Other: Normal saline; Drug: Bupivacaine

• Registration Number: NCT01528722
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-02
• Study First Submitted: 2012-02-04
• Study First Submitted QC: 2012-02-07
• Last Update Submitted: 2012-02-07
• Study First Posted: 2012-02-08
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis

Exclusion Criteria

• patients undergoing planned elective cholecystectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline sham injection	Normal saline	Sham wash and injection with normal saline (09%)
Bupivacaine	Bupivacaine	Bupivacaine injection/wash treatment arm

Primary Outcome Measures

Name	Time	Method
VAS pain score

Secondary Outcome Measures

Name	Time	Method
VRS pain score
Satisfaction score (VAS)
Physiological observations - respiratory rate, oxygen saturation
Analgesic use post operation

Trial Locations

Locations (1)

University Hospitals Coventry and Warwickshire; 🇬🇧 Coventry, Warwickshire, United Kingdom