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CTRI Number  CTRI/2025/12/099529 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Pain relief after kidney stone surgery: A study comparing ultrasound guided erector spinae block with peritubal infiltration. 
Scientific Title of Study   A Comparision of ultrasound guided erector spinae plane blocks versus peritubal infiltration for poatoperative analgesia in percutaneous nephrolithotomy. 
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. Margesh Bharatbhai Thakkar  
Designation  2nd Year Resident Of MD Anaesthesiology 
Affiliation  B.J. MEDICAL COLLEGE,CIVIL Hospital,Ahmedabad 
Address  F3, first floor Department of Anesthesiology, trauma building ,civil hospital, asarwa, Haripura, Ahmedabad.
F3, first floor Department of Anesthesiology, trauma building ,civil hospital, asarwa, Haripura Ahmedabad.
Ahmadabad
GUJARAT
380016
India 
Phone  8511777540  
Fax    
Email  tmargesh15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharthkumar B Parmar 
Designation  MD A naesthesiology 
Affiliation  B.J. MEDICAL COLLEGE,CIVIL Hospital,Ahmedabad 
Address  F3, first floor Department of Anaesthesia , trauma building ,civil hoaspital campus, asarwa, haripura ahmedabad.

Ahmadabad
GUJARAT
380016
India 
Phone  9426332701  
Fax    
Email  drsid25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Siddharthkumar B Parmar 
Designation  MD A naesthesiology 
Affiliation  B.J. MEDICAL COLLEGE,CIVIL Hospital,Ahmedabad 
Address  F3, first floor Department of Anaesthesia , trauma building ,civil hoaspital campus, asarwa, haripura ahmedabad.

Ahmadabad
GUJARAT
380016
India 
Phone  9426332701  
Fax    
Email  drsid25@gmail.com  
 
Source of Monetary or Material Support  
Goverment of Gujarat Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India 
 
Primary Sponsor  
Name  Goverment of Gujarat 
Address  Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Margesh Bharatbhai Thakkar   BJ Medical college and civil hospital  Urology operation theatre, 04 wing 1200 bed hospital, Anesthesia Department
Ahmadabad
GUJARAT 		 8511777540

tmargesh15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee B.J. Medical College Civil hospital Ahmedabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj Ropivacaine given in erector spinae plane in postoperative period   Inj Ropivacaine 0.25% total 20 given in erector spinae plane block for postoperative analgesia  
Comparator Agent  Injection Ropivacaine given for peritubal infiltration. In postoperative period.  Injection Ropivacaine 0.25% total 20 ml given for peritubal infiltration for postoperative analgesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I, II, III undergoing elective surgery under general anesthesia.
Patient having unilateral renal stone who is undergoing for PCNL
willingness of patient.
 
 
ExclusionCriteria 
Details  ASA grade IV,V.
Patient having bilateral renal stone.
Contraindication to giving block.
Patient having neuromuscular disorder and neurological symptoms.
Pregnancy.
Patient giving negative consent for procedure. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia.  To compare duration of analgesia, in first 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor and compare the incidence of adverse effect.  Postoperative 24 hours. 
To assess postoperative hemodynamic parameter in both groups.  Postoperative 24 hours. 
 
Target Sample Size   Total Sample Size="59"
Sample Size from India="59" 
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)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="25" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-10-2026 and end date provided 01-10-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Postoperative pain management after PCNL is important as patient have more pain after PCNL. Erector spinae plane blocks provide more pain relief after procedure with injection Ropivacaine 0.25%.  
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