| CTRI Number |
CTRI/2025/06/089068 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Relief of pain after kidney stone surgery: A study comparing two types of nerve blocks using ropivacaine |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy Between Ultrasound-Guided Paravertebral Block and Erector Spinae Plane Block Using Ropivacaine After Percutaneous Nephrolithotomy in Medical College Kolkata |
| 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 Chayan Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Medical College Kolkata |
| Address |
Room no 1,Third Floor, Green Building, Department of Anaesthesiology and Critical care, Medical College Kolkata,
88, College Street, Kolkata 700073
Kolkata
WEST BENGAL
700073
India |
| Phone |
08420222364 |
| Fax |
|
| Email |
chayan.dcd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjana Ghosh Dastidar Bose |
| Designation |
Professor |
| Affiliation |
Medical College Kolkata |
| Address |
Room no 1,Third Floor, Green Building, Department of Anaesthesiology and Critical care, Medical College Kolkata,
88, College Street, Kolkata 700073
Room no 1,Third Floor, Green Building, Department of Anaesthesiology and Critical care, Medical College Kolkata,
88, College Street, Kolkata 700073
Kolkata
WEST BENGAL
700073
India |
| Phone |
9831291666 |
| Fax |
|
| Email |
anjanag_dastidar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Chayan Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Medical College Kolkata |
| Address |
Room no 1,Third Floor, Green Building, Department of Anaesthesiology and Critical care, Medical College Kolkata,
88, College Street, Kolkata 700073
Room no 1,Third Floor, Green Building, Department of Anaesthesiology and Critical care, Medical College Kolkata,
88, College Street, Kolkata 700073
Kolkata
WEST BENGAL
700073
India |
| Phone |
8420222364 |
| Fax |
|
| Email |
chayan.dcd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical College Kolkata,
88, College Street, Kolkata 7000073,
West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Medical College Kolkata |
| Address |
88, College Street, Kolkata 700073 |
| 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 Chayan Das |
Medical College Kolkata |
SSB OT room, 2nd floor, SSB building, Department of Anaesthesiology and Critical care, Medical College Kolkata,
88, College Street, Kolkata 700073
Kolkata
WEST BENGAL |
08420222364
chayan.dcd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Medical College, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided Erector Spinae Plane Block |
Observation the analgesic efficacy of block for post operative twelve hours |
| Intervention |
Ultrasound guided paravertebral block |
Observation the analgesic efficacy of block for post operative twelve hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for unilateral percutaneous nephrolithotomy under general anesthesia. ASA Grade 1 and 2 patients. Body weight between 50 kg to 70 kg. |
|
| ExclusionCriteria |
| Details |
Patient refused to give consent. Patient with contraindications for local anesthesia. Patient with severe psychiatric disorders. Patient with infection at injection sites. Patients with renal parenchymal disorders. Renal stones which required more than one puncture, supra costal puncture. Intraoperative excessive bleeding. Obesity (BMI more than 30).Patient with history of chronic pain and drug abuse. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Analgesic Efficacy Between Ultrasound-Guided Paravertebral Block and Erector Spinae Plane Block Using Ropivacaine After Percutaneous Nephrolithotomy in Medical College Kolkata |
08 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic Parameter & Side effects of any |
June 2025 TO January 2026 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/08/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
TITLE - COMPARISON OF ANALGESIC EFFICACY BETWEEN ULTRASOUND-GUIDED
PARAVERTEBRAL BLOCK AND ERECTOR SPINAE
PLANE BLOCK USING ROPIVACAINE AFTER PERCUTANEOUS
NEPHROLITHOTOMY IN MEDICAL COLLEGE, KOLKATA Acute postoperative pain after percutaneous
nephrolithotomy surgery often hinders early recovery and may also lead to
chronic post surgical pain, which lowers quality of life. Paravertebral block
is an excellent choice for postoperative analgesia. The erector spinae plane
block is also emerging as an effective
alternative.
Ropivacaine is a long-acting amide local
anaesthetic. It exhibits a similar mechanism of action to other local
anaesthetics in that it reversibly inhibits sodium ion influx in nerve fibers. Ropivacaine has some unique properties.
Ropivacaine is less lipophilic than other local anaesthetics and is less likely
to penetrate large myelinated motor fibers. It, therefore, selectively acts on
the nociceptive
A, B, and C
fibers over the AB (motor) fibers resulting in a relatively reduced motor
blockade. Thus, ropivacaine has a greater degree of motor sensory
differentiation, which can be useful in this scenario where motor blockade is
undesirable. Ropivacaine has
significantly less cardiotoxicity and neurotoxicity. The aim of this study is to
compare the analgesic efficacy of paravertebral block and
erector spinae plane block using Ropivacaine
in preventing acute post surgical pain following Percutaneous nephrolithotomy. |