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CTRI Number  CTRI/2025/08/093555 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of two approaches of nerve block for pain relief after kidney stone surgery. 
Scientific Title of Study   Comparison of ultrasound guided anterior quadratus lumborum block versus subcostal approach to anterior quadratus lumborum block on post operative analgesia in patients undergoing percutaneous nephrolithotomy- Double blinded randomized controlled trial.  
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 Anjana 
Designation  Post graduate 
Affiliation  Sri Manakula Vinayagar Medical College Madagadipet Kalatheerthalkuppam 
Address  PG Quaters Phase 1 Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry
Room no.106 Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry
Pondicherry
PONDICHERRY
605107
India 
Phone  9746646367  
Fax    
Email  anjana619s@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Dilip Chandar 
Designation  Professor 
Affiliation  Sri Manakula Vinayagar Medical College Madagadipet Kalatheerthalkuppam 
Address  Department of Anaesthesia sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry
ROOM NO.107 Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry
Pondicherry
PONDICHERRY
605107
India 
Phone  9993031202  
Fax    
Email  dilipchandar2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anjana S 
Designation  Post graduate 
Affiliation  Sri Manakula Vinayagar Medical College Madagadipet Kalatheerthalkuppam 
Address  PG quaters phase 1 sri manakula vinayagar medical college madagadipet kalitheerthalkuppam pudhucherry
Room no.106 Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry
Pondicherry
PONDICHERRY
605107
India 
Phone  9746646367  
Fax    
Email  anjana619s@gmail.com  
 
Source of Monetary or Material Support  
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL MADAGADIPET KALITHEERTHALKUPPAM PUDUCHERRY INDIA 605107 
 
Primary Sponsor  
Name  Sri Manakula Vinayagar Medical College  
Address  Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry 605107 
Type of Sponsor  Private 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 AnjanaS  Sri Manakula Vinayagar Medical College   Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry
Pondicherry
PONDICHERRY 
09746646367

anjana619s@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH -ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional Approach Of Anterior Quadratum Lumborum Block  Conventional Anterior Quadratus Lumborum Block Will Be Given To Patients Posted For Percutaneous Nephrolithotomy Post Operatively 
Comparator Agent  Subcostal Approach To Anterior Quadratus Lumborum Block  Subcostal Approach To Anterior Quadratus Lumborum Block Will Be Given To Patients Posted For Percutaneous Nephrolithotomy Post Operatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Asa Ps I,Ii,Iii
-Either Gender
-Patient Posted For Elective Percutaneous Nephrolithotomy


 
 
ExclusionCriteria 
Details  -INFECTION AT INJECTION SITE
-HYPERSENSITIVITY TO LOCAL ANAESTHETICS
-SURGERY DONE UNDER GENERAL ANAESTHESIA. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the block duration by determining the time taken for first rescue analgesic between ultrasound guided anterior quadratus lumborum block and subcostal approach to anterior quadratus lumborum block.
 
2hours,4hours,8hours,12hours, 24hours  
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the pain scores at rest (resting numeric rating scale score) at specific time intervals post-operatively.
2.To compare the pain scores at ambulation (Dynamic numeric rating scale score) at 12hrs and 24hrs.
3.To compare the total opioid consumption between ultrasound guided anterior quadratus lumborum block and subcostal approach to anterior quadratus lumborum block.
 
2hours,4hours,8hours,12hours,24hours 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 2 
Date of First Enrollment (India)   05/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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 - 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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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) -  anjana619s@gmail.com

  6. For how long will this data be available start date provided 30-12-2026 and end date provided 18-12-2029?
    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  
All participants will undergo detailed clinical evaluation, including history, examination, routine and relevant investigations, and pre-anaesthetic assessment on the day prior to surgery. Patients will be briefed about the Numeric Rating Scale (0–10) for pain assessment and randomly allocated into two groups using block randomization: Group C (Conventional anterior quadratus lumborum block) and Group S (Subcostal anterior quadratus lumborum block). Written informed consent will be obtained.

Following standard intraoperative monitoring and spinal anaesthesia (17.5 mg of 0.5 percentage hyperbaric Bupivacaine at L3–L4), patients will undergo percutaneous nephrolithotomy in the prone position. At the end of surgery, Group C will receive a conventional anterior quadratus lumborum block and Group S will receive a subcostal approach, both under ultrasound guidance using 20 ml of 0.25 percentage Bupivacaine. The block technique and time will be recorded.

Postoperative pain will be assessed using NRS at rest (2, 4, 8, 12, 24 hours) and during movement (12, 24 hours). Rescue analgesia (IV Tramadol 0.5 mg/kg) will be administered if NRS greater than or equal to 4, with total 24-hour consumption noted. Hemodynamic parameters and side effects such as nausea, vomiting, site pain, hematoma, or local anaesthetic toxicity will be monitored. All outcome assessments will be done by a blinded observer.
 
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