| CTRI Number |
CTRI/2024/01/061363 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between single and dual local anaesthetic injection for pain relief in kidney transplant patients |
|
Scientific Title of Study
|
A comparative study between lateral transversus abdominis plane block versus a dual(lateral+ subcostal) transversus abdominis plane block for post operative analgesia in renal recipients- A prospective randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Sarkar |
| Designation |
DNB Resident |
| Affiliation |
Indraprastha Apollo Hospital, New Delhi |
| Address |
Department of Anaesthesiology, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9503650841 |
| Fax |
|
| Email |
Priyankasngpm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Sarkar |
| Designation |
DNB Resident |
| Affiliation |
Indraprastha Apollo Hospital, New Delhi |
| Address |
Department of Anaesthesiology, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9503650841 |
| Fax |
|
| Email |
Priyankasngpm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meera Kharbanda |
| Designation |
Senior Consultant |
| Affiliation |
Indraprastha Apollo Hospital |
| Address |
Department of Anaesthesiology, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9810063988 |
| Fax |
|
| Email |
Meera.kharbanda@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indraprastha Apollo Hospital, Sarita Vihar, New Delhi |
|
|
Primary Sponsor
|
| Name |
Priyanka Sarkar |
| Address |
Department of Anaesthesiology, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Sarkar |
Indraprastha Apollo Hospital |
Department of Anaesthesia, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi
New Delhi
DELHI |
9503650841
Priyankasngpm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Bio Medical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual (Lateral+ Subcostal) Transversus Abdominis Plane block |
Pre incision USG guided transversus abdominis plane block given with 0.375% ropivacaine at two locations- lateral and subcostal (20ml+ 20ml) plus PCA fentanyl |
| Comparator Agent |
Lateral Transversus Abdominis Plane block |
Pre incision USG guided transversus abdominis plane block given with 0.375% ropivacaine 40 mL by lateral approach plus PCA fentanyl |
| Comparator Agent |
No block |
PCA fentanyl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American Society of Anaesthesiology physical status 3 posted for renal transplantation and consent taken for USG guided transversus abdominis plane block |
|
| ExclusionCriteria |
| Details |
Patient’s refusal to take part in our study
Allergy to any drug administered in study
History of seizures or fits
History of CNS disease with potential for increase in intracranial pressure
Chronic exposure to, or abuse of alcohol or other drugs affecting the CNS
Use of any experimental drug within the last 30 days
Patients with addiction to opioids
Patients with long term usage of anti depressants, anti psychotics, anti convulsants
Patients with coagulopathy and hepatomegaly
Patients taken for re exploration after renal transplantation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess opioid requirement in post operative period up to 24 hours |
6 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess visual analogue scale scores in the first 24 hours of post operative period |
6 hours, 12 hours, 24 hours |
| Assess nausea and sedation scores in the first 24 hours of post operative period |
6 hours, 12 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective randomised controlled trial where we compare the effect of lateral and dual( lateral+ subcostal) transversus abdominis plane blocks on post operative analgesia in renal recipients. The primary outcome is to assess opioid requirement in the first 24 hours of post operative period. The secondary outcome is to assess the VAS scores, nausea and sedation scores in the first 24 hours of post operative period.
|