Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy
Double Blind Sham Controlled Randomised Trial of Intraperitoneal Bupivacaine During Acute Laparoscopic Cholecystectomy
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 4, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedFebruary 8, 2012
February 1, 2012
1 year
February 4, 2012
February 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS pain score
Secondary Outcomes (4)
VRS pain score
Satisfaction score (VAS)
Physiological observations - respiratory rate, oxygen saturation
Analgesic use post operation
Study Arms (2)
Saline sham injection
SHAM COMPARATORSham wash and injection with normal saline (09%)
Bupivacaine
ACTIVE COMPARATORBupivacaine injection/wash treatment arm
Interventions
Eligibility Criteria
You may qualify if:
- patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis
You may not qualify if:
- patients undergoing planned elective cholecystectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Coventry and Warwickshire
Coventry, Warwickshire, CV2 2DX, United Kingdom
Related Publications (1)
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.
PMID: 23742777DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mr
Study Record Dates
First Submitted
February 4, 2012
First Posted
February 8, 2012
Study Start
January 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
February 8, 2012
Record last verified: 2012-02