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CTRI Number  CTRI/2024/08/072743 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 18/08/2024
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 different pain relief techniques for abdominal surgery in children  
Scientific Title of Study   Quadratus lumborum block versus Transversus abdominis plane block for postoperative analgesia in children undergoing abdominal surgeries: a prospective 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 ANULAKSHMI T V 
Designation  Junior resident academic 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  All India Institute of Medical Sciences Bhubaneswar, Room no 406, Academic building, Department of Anesthesiology and Critical Care, Sijua, Patrapada, Khordha, Orissa

Khordha
ORISSA
751019
India 
Phone  7592045981  
Fax    
Email  anulakshmivarier@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bikram Kishore Behera 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  All India Institute of Medical Sciences Bhubaneswar, Room no 406, Academic building, Department of Anesthesiology and Critical Care, Sijua, Patrapada, Khordha, Orissa

Khordha
ORISSA
751019
India 
Phone  9438884047  
Fax    
Email  anaes_bikram@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Bikram Kishore Behera 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  All India Institute of Medical Sciences Bhubaneswar, Room no 406, Academic building, Department of Anesthesiology and Critical Care, Sijua, Patrapada, Khordha, Orissa

Khordha
ORISSA
751019
India 
Phone  9438884047  
Fax    
Email  anaes_bikram@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Khordha, Orissa, PIN 751019, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhubaneswar, 
Address  Sijua, Patrapada, Khordha, Orissa, PIN 751019, India 
Type of Sponsor  Research institution and hospital 
 
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 ANULAKSHMI T V  All India Institute of Medical Sciences Bhubaneswar   Department of Anesthesiology and Critical Care, Department of Paediatric surgery, Paediatric OT complex 4th floor, Paediatric surgery ward 5th floor, Patrapada, Khordha, Orissa, PIN 751019, India
Khordha
ORISSA 		 7592045981

anulakshmivarier@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences Bhubaneswar  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  Quadratus lumborum block  Ultrasound guided Quadratus lumborum block, single shot with Bupivacaine 0.25%, 0.1ml/kg/dermatome.  
Comparator Agent  Transversus abdominis plane block  Ultrasound guided Transversus abdominis plane block, single shot with Bupivacaine 0.25%, 0.1ml/kg/dermatome. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. ASA grade I & II
 
 
ExclusionCriteria 
Details  1. Failure to obtain parental consent
2. Emergency surgeries
3. ASA grade III,IV,V
4. Children who will be electively ventilated postoperatively
5. Past history of allergic reaction to local anesthetic agent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cumulative opioid consumption in terms of iv morphine equivalents in 24 hours after surgery.  Within 24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Pain scores  1hr
2 hr
4 hr
6 hr
8 hr
12 hr
24 hr 
Time to first rescue analgesia  Within 24 hours of surgery 
Number of rescue analgesia  Within 24 hours after surgery 
Postoperative vomiting and retching  Within 24 hours after surgery 
Parent satisfaction score using Likert scale  Within 24 hours after surgery 
Procedure related complications  Within 24 hours after surgery 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   30/08/2024 
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="6"
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 - NO
Brief Summary   Major abdominal surgeries in children is optimally managed with multimodal analgesia, with the goal of reducing opioid use and associated side effects. Regional anesthesia techniques are useful adjuncts of multimodal analgesia for decreasing postoperative pain and opioid consumption. Development of new and accessible nerve blocks and improved ultrasound technology has increased the focus of non-neuraxial regional anesthesia techniques in children.  Transversus abdominis plane (TAP) block and Quadratus lumborum (QL) block provides intraoperative and postoperative analgesia for upper and lower abdominal incisions. Data demonstrating feasibility and safety of these techniques are increasing, but procedure specific evidence for major abdominal surgeries in children is lacking. Thus, our study aims at comparing analgesic efficacy of TAP block and QL block in children undergoing abdominal surgeries. 
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