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Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01528722
Enrollment
42
Registered
2012-02-08
Start date
2009-01-31
Completion date
2010-01-31
Last updated
2012-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Gall Stone Pancreatitis

Keywords

Emergency laparoscopic cholecystectomy, Pain scores, Intraperitoneal local anaesthesia, Cholecystitis

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.

Interventions

DRUGBupivacaine

0.25% 20ml administered intraperitoneal

OTHERNormal saline

sodium chloride 0.9% solution

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis

Exclusion criteria

* patients undergoing planned elective cholecystectomy

Design outcomes

Primary

MeasureTime frame
VAS pain score

Secondary

MeasureTime frame
VRS pain score
Satisfaction score (VAS)
Physiological observations - respiratory rate, oxygen saturation
Analgesic use post operation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026