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CTRI Number  CTRI/2024/09/073692 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of bupivacaine in hernia surgery for post operative pain  
Scientific Title of Study   The analgesic effect and patient satisfaction following bupivacaine infiltration in the extra peritoneal space in patients undergoing laparocopic TAPP repair for unilateral inguinal hernias A 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 Satya Prakash Meena 
Designation  Assosicate Professor 
Affiliation  AIIMS Jodhpur 
Address  Room no. 525, 5th floor , B -block , OPD building , AIIMS Jodhpur

Jodhpur
RAJASTHAN
342001
India 
Phone  8010861072  
Fax    
Email  drsatyaprakash04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Satya Prakash Meena 
Designation  Assosicate Professor 
Affiliation  AIIMS Jodhpur 
Address  Room no. 525, 5th floor , B -block , OPD building , AIIMS Jodhpur

Jodhpur
RAJASTHAN
342001
India 
Phone  8010861072  
Fax    
Email  drsatyaprakash04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Satya Prakash Meena 
Designation  Assosicate Professor 
Affiliation  AIIMS Jodhpur 
Address  Room no. 525, 5th floor , B -block , OPD building , AIIMS Jodhpur

Jodhpur
RAJASTHAN
342001
India 
Phone  8010861072  
Fax    
Email  drsatyaprakash04@gmail.com  
 
Source of Monetary or Material Support  
Research Section, Aiims Jodhpur, Basni , Jodhpur 342001, India 
 
Primary Sponsor  
Name  AIIMS Jodhpur Research Section  
Address  Research Section, Aiims Jodhpur, Basni , Jodhpur , 342001 , Rajastha , 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 Satya Prakash Meena  AIIMS JODHPUR  Department of General Surgery ,AIIMS JODHPUR , Basni , Jodhpur
Jodhpur
RAJASTHAN 		 8010861072

drsatyaprakash04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bupivacaine  Bupivacaine 0.5% , with 2mg/kg dosage through port sites will be infiltrated in extraperitoneal TAPP space after mesh placement and drug will be absorbed from flap and postoperative pain will be assessed at 6 hour , 12 hour , 24 hour after surgery  
Comparator Agent  Normal saline   Normal saline will be infiltrated in extraperitoneal TAPP space after mesh placement and postoperative pain will be assessed at 6 hour , 12 hour , 24 hour after surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  All male patients between specified age undergoing unilateral TAPP will be included  
 
ExclusionCriteria 
Details  Recuurent hernia , Previous laparotomy ,substance abuse or opium addiction , psychiatric patients, uncontrolled comorbidities, history of drug allergy  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Analgesic effect of bupivacine infiltration into port wounds and extraperitoneal space compared to placebo (normal saline) after 6 ,12 , 24 hours of surgery   VAS pain score after 6 ,12 , 24 hours of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To compare patient satisfaction level  At time of discharge from the hospital ( 1 or 2 days after OT ) 
 
Target Sample Size   Total Sample Size="202"
Sample Size from India="202" 
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)   21/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/09/2024 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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

  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 [Drsatyaprakash04@gmail.com].

  6. For how long will this data be available start date provided 10-06-2024 and end date provided 30-05-2030?
    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 study will include all adult male inguinal hernia patients undergoing TAPP. Total 202 patients will be randomized for the study just before the procedure. The study patients will be introduced with infiltration of 0.5% bupivacaine and other patients will be introduced with normal saline in the extra-peritoneal space and port site. The study patients will be compared for postoperative outcomes likes pain at 6, 12 and 24 hours after surgery 
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