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CTRI Number  CTRI/2026/04/107727 [Registered on: 07/04/2026] Trial Registered Prospectively
Last Modified On: 02/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare two methods of pain control (quadratus lumborum block and caudal block) in children having abdominal surgery 
Scientific Title of Study   A randomised trial to assess the efficacy of ultrasound guided quadratus lumborum block vs caudal block in paediatric population undergoing abdominal surgeries under general anaesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Haseeb Mehmood 
Designation  JUNIOR RESIDENT 
Affiliation  Jawaharlal Nehru Medical College, Aligarh Muslim University  
Address  Department of Anesthesiology and Critical care Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh Uttar Pradesh India 202002

Aligarh
UTTAR PRADESH
202002
India 
Phone  09045798657  
Fax    
Email  sofihaseeb88@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  FARAH NASREEN 
Designation  ASSISTANT PROFESSOR 
Affiliation  Jawaharlal Nehru Medical College, Aligarh Muslim University  
Address  Department of Anesthesiology and Critical care Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh Uttar Pradesh India 202002

Aligarh
UTTAR PRADESH
202002
India 
Phone  9897067670  
Fax    
Email  kazmifarah@gmail.com  
 
Details of Contact Person
Public Query  
Name  FARAH NASREEN 
Designation  ASSISTANT PROFESSOR 
Affiliation  Jawaharlal Nehru Medical College, Aligarh Muslim University  
Address  Department of Anesthesiology and Critical care Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh Uttar Pradesh India 202002

Aligarh
UTTAR PRADESH
202002
India 
Phone  9897067670  
Fax    
Email  kazmifarah@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of Anesthesiology and Critical care Jawaharlal Nehru Medical College AMU 
Address  Jawaharlal Nehru Medical College, Aligarh Muslim University Aligarh Uttar Pradesh India 202002 
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 Farah Nasreen  Jawaharlal Nehru Medical College, AMU, Aligarh  Department of Anesthesiology Aligarh Muslim University Aligarh Uttar pradesh India 202002
Aligarh
UTTAR PRADESH 		 05712721138

kazmifarah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, JAWAHARLAL NEHRU MEDICOLLEGE& HOSPITAL, FACULTY OF MEDICINE, ALIGARH MUSLIM UNIVERSITY  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 
Comparator Agent  Caudal Block  Patients will recieve 1ml/kg, 0.25% Bupivacaine as caudal block. 
Intervention  Quadratus Lumborum Block  Patients will recieve 0.5ml/kg, 0.25% Bupivacaine as quadratus lumborum block on each side 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Consent of patients parents or guardians
ASA grade I and II
Weight between 10kg and 30 kg
Patients undergoing abdominal surgery under general anaesthesia 
 
ExclusionCriteria 
Details  Patient parent or guardian refusal
History of allergy to analgesics
Skin infection at puncture site
Deranged coagulation profile
Pulmonary, cardiac or any otherelective systemic disorder and congenital anomalies
Anticipated difficult airway 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to first rescue analgesia  Time to first rescue analgesia
(in minutes) measured from completion of block to administration of first resuce analgesic within the first 24 hours post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on intraoperative hemodynamic parameters
 		 Baseline, every 15 minutes during the surgery 
Total analgesic consumption in 24 hours.
 		 After 24 hours 
Patient satisfaction score.
 		 After 24 hours 
Complications or adverse effects associated with block or drug use  Till 24 hours after surgery 
 
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   Phase 4 
Date of First Enrollment (India)   13/04/2026 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sofihaseeb88@gmail.com].

  6. For how long will this data be available start date provided 05-05-2028 and end date provided 28-05-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The Quadratus Lumborum(QL) block is an emerging regional anesthetic technique with significant potential for clinical benefit. It was first described by Blanco in 2007. QL block provides visceral as well as somatic analgesia, relieves acute as well as chronic pain and can be utilized for analgesia at thoracic , abdominal levels as well as lower extremity with minimal side effects. The use of ultrasound (US) guided nerve block has resulted in the revolutionary change in the field of regional anaesthesia in pediatric patients. Studies have shown that QLB have opioid sparing effect in pediatric patient, even in major surgeries. While the literature for the use of QLB in adult patients undergoing major surgeries is abundantly available online the same cannot be said for the paediatric population. This study aims to provide more insight into the efficacy of QLB against the more convential Caudal block in the paediatric population. 
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