Home » Trials » SLCTR/2013/031
Randomized controlled trial of Transversus Abdominis Plane (TAP) block vs. local infiltration for pain relief in kidney transplant recipients.
-
SLCTR Registration Number
SLCTR/2013/031
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Randomized controlled trial of Transversus Abdominis Plane (TAP) block vs. local infiltration for pain relief in kidney transplant recipients.
Public Title of Trial
Comparison of two methods of pain relief for patients after kidney transplantation
Disease or Health Condition(s) Studied
Post operative pain management
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-13-025 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Is transverse abdominis plane (TAP) block better than local infiltration in managing post -operative pain after kidney transplantation?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Consenting patients will be randomized into two arms. The first arm (A) will undergo a TAP block post induction of anaesthesia with 0.25% Bupivacaine 20ml. The second arm (B) will receive local anaesthetic infiltration in to surgical incision after skin closure with 0.25% bupivacaine 20ml, before reversal of patient from general anaesthesia. The TAP block would be administered by a single anaesthetist (Principal investigator) for all patients and the skin infiltration would be done by a single surgeon for all patients.
Both groups will be the same with regards to anaesthetic and surgical technique used, the drugs used, the kg bodyweight drug doses used and the monitoring done.
Inclusion criteria
All consenting patients undergoing kidney transplantation
Exclusion criteria
Primary outcome(s)
|
1.
Changes in pain score using (using a visual analogue and numerical rating scale) |
[ At 2hrs, 10hrs and 24hrs post operatively ] |
|
2.
Duration of pain relief |
[ At 2hrs, 10hrs and 24hrs post operatively ] |
Secondary outcome(s)
|
1.
Need for rescue analgesics (based on change in pain scores) |
[ At 2hrs, 10hrs and 24hrs post operatively ] |
Target number/sample size
52
Countries of recruitment
Sri Lanka
Anticipated start date
2013-10-15
Anticipated end date
2014-05-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-06-20
Approval number
EC-13-025
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Anuja Abayadeera
Professor of Anaesthesiology
Department of Surgery,
Faculty of Medicine, University of Colombo
No. 25, Kynsey Road, Colombo 8
Sri Lanka
0777779868
0112671846
aabayadeera@gmail.com
Contact Person for Public Queries
Prof. Anuja Abayadeera
Professor of Anaesthesiology
Department of Surgery,
Faculty of Medicine, University of Colombo
No. 25, Kynsey Road, Colombo 8
Sri Lanka
0777779868
0112671846
aabayadeera@gmail.com
Primary study sponsor/organization
Faculty of Medicine, University of Colombo
No. 25, Kynsey Road, Colombo 8
Sri Lanka
+94112695300
+94112691581
http://www.med.cmb.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
