Back to resultsIntraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy
Primary Purpose
Gall Stones
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bupivocaine
0.9% normal saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Gall Stones focused on measuring Local anaesthetic, Laparoscopic cholecystectomy, Pain scores, Bupivocaine, Day case surgery
Eligibility Criteria
Inclusion Criteria:
- Elective laparoscopic cholecystectomy
- 18 years old or over
Exclusion Criteria:
- Emergency surgery
- Under 18 year olds
Sites / Locations
- UHCW NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Active Comparator
Arm Label
Control
Subperitoneal injection
Topical LA
Arm Description
Sham wash, sham injection
Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder
Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm
Outcomes
Primary Outcome Measures
VAS pain score
Secondary Outcome Measures
Time to ambulation
The first time the patient gets out of bed and walks following the procedure
Same day discharge
VRS pain scores
Immediately following the operation
Full Information
NCT ID
NCT01090882
First Posted
March 18, 2010
Last Updated
March 22, 2010
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01090882
Brief Title
Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy
Official Title
Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash.
Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gall Stones
Keywords
Local anaesthetic, Laparoscopic cholecystectomy, Pain scores, Bupivocaine, Day case surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham wash, sham injection
Arm Title
Subperitoneal injection
Arm Type
Experimental
Arm Description
Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder
Arm Title
Topical LA
Arm Type
Active Comparator
Arm Description
Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm
Intervention Type
Drug
Intervention Name(s)
Bupivocaine
Other Intervention Name(s)
marcaine
Intervention Description
20ml 0.25% at beginning of operation
Intervention Type
Drug
Intervention Name(s)
0.9% normal saline solution
Other Intervention Name(s)
marcaine
Intervention Description
20ml 0.9% NaCl
Primary Outcome Measure Information:
Title
VAS pain score
Time Frame
1, 4, 8 hours after operation and at discharge
Secondary Outcome Measure Information:
Title
Time to ambulation
Description
The first time the patient gets out of bed and walks following the procedure
Time Frame
following the procedure
Title
Same day discharge
Time Frame
24 hours
Title
VRS pain scores
Description
Immediately following the operation
Time Frame
Every 10 minutes in theatre recovery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Elective laparoscopic cholecystectomy
18 years old or over
Exclusion Criteria:
Emergency surgery
Under 18 year olds
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith J Roberts, MRCS
Organizational Affiliation
University Hospital Coventry and Warwickshire NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHCW NHS Trust
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21638181
Citation
Roberts KJ, Gilmour J, Pande R, Nightingale P, Tan LC, Khan S. Efficacy of intraperitoneal local anaesthetic techniques during laparoscopic cholecystectomy. Surg Endosc. 2011 Nov;25(11):3698-705. doi: 10.1007/s00464-011-1757-3. Epub 2011 Jun 3.
Results Reference
derived
Learn more about this trial
Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy
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