Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

NCT ID: NCT01528722

Last Updated: 2012-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

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.

Conditions

Cholecystitis; Gall Stone Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Saline sham injection

Sham wash and injection with normal saline (09%)

Group Type: SHAM_COMPARATOR

Normal saline

Intervention Type: OTHER

sodium chloride 0.9% solution

Bupivacaine

Bupivacaine injection/wash treatment arm

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

0.25% 20ml administered intraperitoneal

Interventions

Bupivacaine

0.25% 20ml administered intraperitoneal

Intervention Type: DRUG

Normal saline

sodium chloride 0.9% solution

Intervention Type: OTHER

Other Intervention Names

Marcaine

Eligibility Criteria

Inclusion Criteria

• patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis

Exclusion Criteria

• patients undergoing planned elective cholecystectomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Keith Roberts

Mr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospitals Coventry and Warwickshire

Coventry, Warwickshire, United Kingdom

Countries

United Kingdom

References

Roberts KJ, Gilmour J, Pande R, Hodson J, Lam FT, Khan S. Double-blind randomized sham controlled trial of intraperitoneal bupivacaine during emergency laparoscopic cholecystectomy. Hepatobiliary Pancreat Dis Int. 2013 Jun;12(3):310-6. doi: 10.1016/s1499-3872(13)60049-1.

Reference Type: DERIVED

PMID: 23742777 (View on PubMed)

Other Identifiers

Acute lap chole RCT

Identifier Type: -

Identifier Source: org_study_id