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CTRI Number  CTRI/2025/09/094533 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparision of local anesthetics with and without adjuvant in transversus abdominis plane block for postoperative pain relief in infants . 
Scientific Title of Study   To compare injection bupivacaine(0.75mg/kg) and injection bupivacaine (0.5mg/kg)+ injection lignocaine (2mg/kg) in transversus abdominis plane block for postoperative analgesia in infants undergoing abdominal surgery. 
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 Shreya M S 
Designation  junior resident 2 
Affiliation  Sapthagiri Institute Of Medical Sciences And Research Centre 
Address  sapthagiri institute of medical science and research centre deptarment of anesthesia hesargatta banglore ,karnataka-560090

Bangalore
KARNATAKA
560090
India 
Phone  09483679128  
Fax    
Email  77shreya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashanthprabhu J 
Designation  professor in department of anesthesiology 
Affiliation  Sapthagiri Institute Of Medical Sciences And Research Centre 
Address  sapthagiri institute of medical science and research centre deptarment of anesthesia hesargatta banglore ,karnataka-560090

Bangalore
KARNATAKA
560090
India 
Phone  9035067161  
Fax    
Email  prashanthjnpl@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prashanthprabhu J 
Designation  professor in department of anesthesiology 
Affiliation  Sapthagiri Institute Of Medical Sciences And Research Centre 
Address  sapthagiri institute of medical science and research centre deptarment of anesthesia hesargatta banglore ,karnataka-560090

Bangalore
KARNATAKA
560090
India 
Phone  9035067161  
Fax    
Email  prashanthjnpl@gmail.com  
 
Source of Monetary or Material Support  
sapthagiri institute of medical science and research centre 
 
Primary Sponsor  
Name  Sapthagiri Institute of Medical Science and Research Center 
Address  15, Hesarghatta Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090 
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 Shreya M S  Sapthagiri hospital  sapthagiri institute of medical science and research centre department of anesthesiology OT number 10 4th floor super-speciality building hesargatta road navy layout banglore-560090
Bangalore
KARNATAKA 		 09483679128

77shreya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sapthagiri institute of medical sciences and research center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bupivacaine 0.5 mg per kg with Lignocaine 1 mg per kg  Combination of Bupivacaine 0.5 mg per kg and Lignocaine 1 mg per kg administered as a surgeon performed Transversus Abdominis Plane block under aseptic precautions at the end of surgery. 
Intervention  Bupivacaine 0.75 mg per kg  Bupivacaine 0.75 mg per kg ,for Transversus Abdominis Plane block under aseptic precautions at the end of surgery by surgeon 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  12.00 Month(s)
Gender  Both 
Details  Infants aged from birth to 12 months undergoing abdominal surgery.
ASA physical status I and II.
Parents or guardians willing to provide informed written consent. 
 
ExclusionCriteria 
Details  Local infection at the block site.
Known hypersensitivity or allergy to bupivacaine or lignocaine. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
postoperative analgesia using Neonatal Infant Pain Scale (NIPS) and total rescue analgesic requirement within 24 hours after surgery.  24hours 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   24/09/2025 
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="0"
Months="8"
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 - NO
Brief Summary   A prospective randomized controlled study comparing injection bupivacaine 0.75 mg per kg with injection bupivacaine 0.5 mg per kg plus injection lignocaine 2 mg per kg for postoperative analgesia in surgeon-administered Transversus Abdominis Plane block in infants undergoing abdominal surgery.
.The primary outcome is to compare postoperative pain scores using NIPS and total rescue analgesic requirement within 24 hours. This trial is registered to promote safe and effective pain management strategies in infants undergoing surgery.
 
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