Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

U

University Hospitals Coventry and Warwickshire NHS Trust

Status

Completed

Conditions

Cholecystitis
Gall Stone Pancreatitis

Treatments

Other: Normal saline
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01528722
Acute lap chole RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis

Exclusion criteria

patients undergoing planned elective cholecystectomy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

42 participants in 2 patient groups

Saline sham injection
Sham Comparator group
Description:
Sham wash and injection with normal saline (09%)
Treatment:
Other: Normal saline
Bupivacaine
Active Comparator group
Description:
Bupivacaine injection/wash treatment arm
Treatment:
Drug: Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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