Home » Trials » SLCTR/2016/011
A double blinded randomized control trial on the effects of standard local infiltration vs laparoscopic guided transverse abdominis plane block for pain relief in laparoscopic cholecystectomy
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SLCTR Registration Number
SLCTR/2016/011
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A double blinded randomized control trial on the effects of standard local infiltration vs laparoscopic guided transverse abdominis plane block for pain relief in laparoscopic cholecystectomy
Public Title of Trial
A study comparing two different methods of pain relief following cholecystectomy
Disease or Health Condition(s) Studied
Post cholecystectomy pain relief
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P/163/10/2015 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
What is the efficacy of laparoscopic guided transverse abdominis plane block in comparison with conventional port site infiltration for postoperative pain relief following laparoscopic cholecystectomy?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
The study will be carried out in wards 19 and 20 of the North Colombo Teaching Hospital, Ragama, Sri Lanka.
Consenting patients meeting the inclusion/exclusion criteria will be allocated using random number tables into either the intervention or control arm immediately prior to surgery.
The intervention arm will receive unilateral sub costal transverse abdominis plane block with 40ml of 0.25% plain bupivacaine + local infiltration of 0.5% plain bupivacaine 5-10ml at each port sites. (The port sites will be epigastric, right iliac fossa, right hypochondrium and umbilical.)
The control arm will receive only local infiltration of 0.5% plain bupivacaine 5-10ml at each port sites. (The port sites will be epigastric, right iliac fossa, right hypochondrium and umbilical.)
The interventions will be carried out by an investigator and the patients then handed over to the surgeon who will be blind to the intervention status of the patient. All interventions will take place once the patient is under general anaesthesia, and thus blind to their intervention status.
Outcomes will be assessed by an independent investigator who will also be blinded to the intervention status.
Inclusion criteria
All patients undergoing elective laparoscopic cholecystectomy
Exclusion criteria
Primary outcome(s)
|
1.
Need for post-operative rescue analgesia with sub cutaneous morphine |
[ At 36 hours post operatively ] |
Secondary outcome(s)
|
1.
Post operative pain (assessed by visual analog score) |
[ At 6,12,18,24 & 36 hours after the surgery. ] |
|
2.
Duration of immobilization |
[ Time taken to walk to the washroom after the surgery. ] |
|
3.
Occurrence of post operative vomiting |
[ 6 hourly up to 36 hours after the surgery ] |
|
4.
Duration of hospital stay |
[ At time of discharge ] |
Target number/sample size
90 (45 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2016-05-01
Anticipated end date
2016-11-01
Date of first enrollment
2016-04-24
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2015-10-14
Approval number
P/163/10/2015
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Rohan Chaminda Siriwardana
Consultant hepatobiliary surgeon
Department of Surgery,
Faculty of Medicine,
Ragama
Tel: 0775544015
Mob: 0777250213
rohansiriwardana@yahoo.com
Contact Person for Public Queries
Dr. Rohan Chaminda Siriwardana
Consultant hepatobiliary surgeon
Department of Surgery,
Faculty of Medicine,
Ragama
Tel: 0775544015
Mob: 0777250213
rohansiriwardana@yahoo.com
Primary study sponsor/organization
Department of Surgery, Faculty of Medicine, University of Kelaniya
Thalagolla Rd, Ragama,
Sri Lanka
Tel: +94112961000
Fax: +94112958337
Web: http://www.kln.ac.lk/medicine/depts/surgery/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
