| CTRI Number |
CTRI/2024/08/072594 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
15/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
For post operative pain management in Percutaneous nephrolithotomy, comparison between USG guided erector spinae muscle plane block and local anaestheic infiltration at incision site. |
|
Scientific Title of Study
|
Clinical comparison of USG guided erector spinae plane block and local anaesthetic infiltration at the incision site for postoperative analgesia in percutaneous nephrolithotomy - A Prospective Randomised Parallel Group 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 |
Dr Ravindra Kumar Gehlot |
| Designation |
Professor |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesiology, RNT medical college Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9468694902 |
| Fax |
|
| Email |
dr.rgehlot.2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Kumar Gehlot |
| Designation |
Professor |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesiology, RNT medical college Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9468694902 |
| Fax |
|
| Email |
dr.rgehlot.2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amanpreet Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesiology, RNT medical college Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8769263109 |
| Fax |
|
| Email |
amankataria1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT Complex, Super
Speciality Block, RNT Medical college Udaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
Department of Anaesthesiology, RNT medical college Udaipur, Rajasthan 313001 |
| Type of Sponsor |
Government 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 |
| Dr Amanpreet Singh |
Maharana Bhupal Government Hospital |
OT Complex, Super Speciality Block, RNT Medical college
Udaipur
RAJASTHAN |
8769263109
amankataria1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT medical college and Controller and attached hospitals Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local Infiltraion of Local Anesthetic agent |
20ml of 0.375% ropivaciane at the incision site |
| Intervention |
USG guided Erector Spinae Plane block |
20ml of 0.375% ropivacaine at T8 level |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society of anesthesiologist Physical status I-II.
Scheduled for elective unilateral percutaneous Nephrolithotomy under GA. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patient with
a. Coagulopathies or on anticoagulant medication
b. Complex stones requiring more than two renal access punctures
c. with absolute contraindications to ESPB
d. Low cognitive function that would make VAS score difficult to assess.
3. History of allergic reaction to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare total analgesic consumption |
In 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare pain relief using visual analog scale (VAS) score.
2. To study duration for the first analgesic requirement.
3. To observe any hemodynamic changes.
4. Adverse effects / complications if any. |
In 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/08/2024 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
The aim of the study
will be to compare the
efficacy of ultrasonography (USG) guided ESPB with local anesthetic
infiltration at the incision site using Ropivacaine (0.375%) in providing
postoperative analgesia following PCNL. |