| CTRI Number |
CTRI/2025/03/082410 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two pain control techniques for postoperative pain control in patients undergoing kidney Transplant surgery |
|
Scientific Title of Study
|
Comparison of Intrathecal Morphine versus Transversus abdominis plane block for postoperative pain control in patients undergoing kidney Transplantation - a prospective randomised 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 |
Saurabh mittal |
| Designation |
senior resident |
| Affiliation |
Mahatma gandhi medical college and hospital jaipur, rajasthan |
| Address |
room no.1, dept. of anaeshesia,mahatma gandhi medical college and hospital jaipur, rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
|
| Fax |
|
| Email |
saurabh.mittal013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vipin kumar goyal |
| Designation |
head |
| Affiliation |
Mahatma gandhi medical college and hospital jaipur, rajasthan |
| Address |
dept. of anaesthesia, Mahatma gandhi medical college and hospital jaipur, rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
8087439644 |
| Fax |
|
| Email |
dr.vipin28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saurabh mittal |
| Designation |
SR |
| Affiliation |
Mahatma gandhi medical college and hospital jaipur, rajasthan |
| Address |
room no.1, dept. of anaesthesia,Mahatma gandhi medical college and hospital jaipur, rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
8087439644 |
| Fax |
|
| Email |
saurabh.mittal013@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
mahatma gandhi medical college and hospitalJaipur |
| Address |
mahatma gandhi medical college and hospital jaipur, rajasthan, 302022 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Saurabh mittal |
Mahatma gandhi medical college and hospital |
room no. 1,dept of anaesthesia,Mahatma gandhi medical college and hospital
Jaipur
RAJASTHAN |
8087439644
saurabh.mittal013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, (2) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal morphine |
With patient in lateral position, intervertebral space L3-L4 is palpated. A 25 G Quincke needle will be inserted and after confirmation of free flow of CSF and A 25 G Quincke needle will be inserted and a total volume of 1 ml (100 mcg (0.1 ml) morphine along with 0.9 ml normal saline) is injected. |
| Intervention |
Transverse abdominal plane block |
patients will be given unilateral ultrasound guided transversus abdominus plane block with 20 ml of 0.5 % ropivacaine mixed with dexmedetomidine 1 mcg/kg after induction of general anaesthesia following the same standard operating procedure protocol. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Undergo Kidney transplant surgery |
|
| ExclusionCriteria |
| Details |
Patient with dilated cardiomyopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effect of intrathecal morphine versus Transversus abdominus plane (TAP) block, in terms of quality of analgesia.
|
1 hours, 6 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare in terms of duration of analgesia & post operative analgesics consumption.
To observe any procedure & drug related complication like hematoma, nausea, vomiting, pruritis & sedation.
|
0,3,6,12,18,24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
With the hypothesis that both intra-thecal morphine and ultrasound guided TAP block has effect on post operative pain management So this study is being planned to compare and evaluate both modalities and observe the duration, quality of analgesia and post operative analgesic consumption in the patients undergoing kidney transplantation. |