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CTRI Number  CTRI/2022/06/043486 [Registered on: 24/06/2022] Trial Registered Prospectively
Last Modified On: 20/06/2022
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 between ultrasound guided Transversus abdominis plane block and local infiltration in paediatric laparoscopic surgeries to find out better and safe technique for post operative pain relief in children 
Scientific Title of Study   A Randomised interventional prospective study on comparison of ultrasound guided Transversus abdominis plane block versus local infiltration for postoperative analgesia in paediatric laparoscopic surgeries at Sms medical College Jaipur. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratibha Rathore 
Designation  Associate Professor 
Affiliation  SMS Medical college 
Address  Department of Anaesthesiology SMS Medical college Adarsh Nagar Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9414446473  
Fax    
Email  pratibha.rathore3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratibha Rathore 
Designation  Associate Professor 
Affiliation  SMS Medical college 
Address  Department of Anaesthesiology SMS Medical college Adarsh Nagar Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9414446473  
Fax    
Email  pratibha.rathore3@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Seethal AR 
Designation  Junior resident 
Affiliation  SMS Medical college 
Address  Department of Anaesthesiology SMS Medical college Adarsh Nagar Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9847929875  
Fax    
Email  seethalarseethu@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology,SMS Medical college and attached hospitals,jaipur  
 
Primary Sponsor  
Name  Department of anaesthesiology SMS Medical collegeAdarsh Nagar jaipur  
Address  JLN Marg,Adarsh nagar ,jaipur 
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 Seethal AR  SMS Medical college   Department of Anaesthesiology,Second floor,Dhanvantri OPD block,JLN Marg, Adarsh Nagar,Jaipur, Pin 302004
Jaipur
RAJASTHAN 		 9847929875

seethalarseethu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sms medical college and attached hospitals, jaipur  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  Local infiltration at Port site with ropivacaine  Local infiltration at laparoscopic port insertion site using .2% ropivacaine at a dose of .4ml/kg 
Intervention  Ultrasound guided transversus abdominis plane block using ropivacaine  Ultrasound guided transversus abdominis plane block given bilaterally using .2% ropivacaine 0.4 ml/kg 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Patients of ASA grade I and II
2.Patients undergoing elective laparoscopic surgeries 
 
ExclusionCriteria 
Details  1.Lack of consent
2.Surgical scar or distorted anatomy at the site of injection
3.Known allergy to local anaesthetics
4.Children with known cardiovascular,respiratory,hepatic or renal disease
5.Patients on anticoagulant therapy and history of coagulation disorders
6.Local infection at the proposed site of puncture for TAP block
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain score  At the end of surgery,at 15 minutes,30 minutes,hourly upto 6 hours,at 12 hours and at 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters(Heart rate,Systolic blood pressure,diastolic blood pressure,mean blood pressure,spo2  Baseline,After induction,After TAP block or local infiltration,After incision,every 15 minutes till the end of 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   N/A 
Date of First Enrollment (India)   29/06/2022 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Regional anaesthesia is an essential aspect of modern paediatric anaesthesia which provides superior and long lasting analgesia without the risk of respiratory depression.The purpose of the study is to find out a better and safe technique for postoperative pain relief in children undergoing laparoscopic surgery.We compare the analgesic efficacy of ultrasonography guided transversus abdominis plane block with local port site infiltration  in children undergoing laparoscopic surgeries.We hypothesised that there is no significant difference in analgesic efficacy between the two groups and the study was designed to test this hypothesis.  
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