Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy
Primary Purpose
Cholecystitis, Gall Stone Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bupivacaine
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis focused on measuring Emergency laparoscopic cholecystectomy, Pain scores, Intraperitoneal local anaesthesia, Cholecystitis
Eligibility Criteria
Inclusion Criteria:
- patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis
Exclusion Criteria:
- patients undergoing planned elective cholecystectomy
Sites / Locations
- University Hospitals Coventry and Warwickshire
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Saline sham injection
Bupivacaine
Arm Description
Sham wash and injection with normal saline (09%)
Bupivacaine injection/wash treatment arm
Outcomes
Primary Outcome Measures
VAS pain score
Secondary Outcome Measures
VRS pain score
Satisfaction score (VAS)
Physiological observations - respiratory rate, oxygen saturation
Analgesic use post operation
Full Information
NCT ID
NCT01528722
First Posted
February 4, 2012
Last Updated
February 7, 2012
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01528722
Brief Title
Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy
Official Title
Double Blind Sham Controlled Randomised Trial of Intraperitoneal Bupivacaine During Acute Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Gall Stone Pancreatitis
Keywords
Emergency laparoscopic cholecystectomy, Pain scores, Intraperitoneal local anaesthesia, Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline sham injection
Arm Type
Sham Comparator
Arm Description
Sham wash and injection with normal saline (09%)
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Bupivacaine injection/wash treatment arm
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
0.25% 20ml administered intraperitoneal
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
sodium chloride 0.9% solution
Primary Outcome Measure Information:
Title
VAS pain score
Secondary Outcome Measure Information:
Title
VRS pain score
Title
Satisfaction score (VAS)
Title
Physiological observations - respiratory rate, oxygen saturation
Title
Analgesic use post operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis
Exclusion Criteria:
patients undergoing planned elective cholecystectomy
Facility Information:
Facility Name
University Hospitals Coventry and Warwickshire
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23742777
Citation
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.
Results Reference
derived
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Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy
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