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CTRI Number  CTRI/2025/07/091048 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
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   Comparison of two ultrasound guided regional blocks for post operative analgesia in laparoscopic lower abdominal surgeries 
Scientific Title of Study   Comparison between ultrasound guided quadratus lumborum block and transverse abdominis plane block for post operative analgesia in patients undergoing laparoscopic lower abdominal surgeries. 
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. Shameemu Rahman P 
Designation  PG Resident 
Affiliation  Army hospital Research and Referral 
Address  Main OT complex Second floor Dept of anaesthesiology and critical care Army hospital R and R Delhi cantt 110010

New Delhi
DELHI
110010
India 
Phone  7767953573  
Fax    
Email  shameemurahmanp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Josemine Davis 
Designation  Professor  
Affiliation  Army hospital Research and Referral 
Address  Main OT complex Second floor Dept of anaesthesiology and critical care Army hospital R and R Delhi cantt 110010

New Delhi
DELHI
110010
India 
Phone  9764623542  
Fax  Nil  
Email  shameemurahmanp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shameemu Rahman P 
Designation  PG Resident 
Affiliation  Army hospital Research and Referral 
Address  Main OT Department of anaesthesiology Second floor Army hospital Research and Referral Delhi Cantt

New Delhi
DELHI
110010
India 
Phone  7767953573  
Fax    
Email  shameemurahmanp@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Army hospital referral and research 
Address  Department of Anaesthesiology and critical care Army hospital Referral and Research Near Subhroto park Dhaula Khuan 110010 
Type of Sponsor  Other [Self] 
 
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 Shameemu Rahman P  Army hospital Research and Referral  Main OT Department of anaesthesiology Second floor Army Hospital R&R Delhi cantt Dhaula khuan 110010
South West
DELHI 		 7767953573

shameemurahmanp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Army Hospital R and R,Delhi Cantt  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age 18-65 ASA I &II NO COAGULOOATHIES  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TAP VS QL  Out sample size of 80 lower abdominal laparoscopic surgeries 40 will be given quadratus lumborum block randomly for post operative analgesia And 40 will be given transversus abdominis plane block. Duration of study will be 18 months or till sample size complete, whichever is achieved first 
Comparator Agent  VAS SCORE  Comparison of post operative analgesia of both blocks will be compared with VAS score. Duration of study will be 18 months or till sample size complete, whichever is achieved first 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I and II
BMI less than 30
Scheduled for elective laparoscopic lower abdominal surgeries 
 
ExclusionCriteria 
Details  Failed to give consent
Any coagulopathies
Allergic to local anaesthetic drugs
Less than 18 yrs and more than 65 yrs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison between analgesic effects of quadratus lumborum block and transversus abdominis block in patients underwent laparoscopic lower abdominal surgeries  0,1,3,6,12,24 hrs post operative 
 
Secondary Outcome  
Outcome  TimePoints 
Compare time taken to administer block
Compare adverse effects
Compare rescue analgesic requirements
Compare patient satisfaction  		 0,1,3,6,12,24 hrs post operative  
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   27/07/2025 
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="1"
Months="0"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 [shameemurahmanp@gmail.com].

  6. For how long will this data be available start date provided 23-06-2026 and end date provided 23-05-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   76 individuals undergoing laparoscopic lower abdominal surgeries will be divided randomly into 2 groups and will be given TAP block and QL block randomly. It’s a single blinded study in which patient is unaware about type of block received. 0.25% Bupivacaine 20ml will be used for this study. Post analgesic effect will be observed at 0 1 3 6 12 18 &24 hours using visual analogue score. 
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