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CTRI Number  CTRI/2024/06/068392 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study on two different doses of buprenorphine with levobupivacaine in abdoiminal nerve block for pain relief in inguinal hernia surgeries  
Scientific Title of Study   A Comparative study on two different doses of buprenorphine with levobupivacaine in Transversus abdominis plane block for pain relief following inguinal hernia repair-Prospective double blind randomized control 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  Srirama krishnan 
Designation  Post graduate  
Affiliation   
Address  Department of Anaesthesialogy and critical care. Sri Venkateshwaraa medical college hospital and research center No.13-A, pondy-villupuram main road, Ariyur,

Pondicherry
PONDICHERRY
605107
India 
Phone  8610144450  
Fax    
Email  sriramakrishnan247@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Chandraleela S 
Designation  Associate professor  
Affiliation   
Address  Department of Anaesthesia Venkateshwaraa medical college hospital and research center,No.13-A,pondy-villupuram main road,Ariyur,

Pondicherry
PONDICHERRY
605102
India 
Phone  9176529672  
Fax    
Email  drchandruz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Srirama krishnan 
Designation  Post graduate  
Affiliation   
Address  Department of Anaesthesiology and critical care, Venkateshwaraa medical college hospital and research center,No.13-A,pondy-villupuram main road,Ariyur,

Pondicherry
PONDICHERRY
605102
India 
Phone  8610144450  
Fax    
Email  sriramakrishnan247@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateshwaraa medical college hospital and research center, No.13-A,pondy-villupuram main road,ariyur,Puducherry,India, 605102 
 
Primary Sponsor  
Name  Dr srirama krishnan 
Address  Sri Venkateshwaraa medical college hospital and research center, no.13-A,pondy-villupuram main road,Ariyur,Puducherry,India, 605102 
Type of Sponsor  Other [Self(principal investigator)] 
 
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 
Srirama krishnan   Sri Venkateshwaraa medical college hospital and research center   Department of Anaesthesia, ot complex,room no.1,pondy-villupuram main road, Ariyur,
Pondicherry
PONDICHERRY 		 8610144450

Sriramakrishnan247@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable   Not applicable  
Intervention  Transversus abdominis plane block   Group-A 0.25% Levobupivacaine(20ml)+0.15mg buprenorphine. Group-B 0.25% Levobupivacaine(20ml)+0.3mg buprenorphine. Will be given at Transversus abdominis plane to find out pain relief after unilateral inguinal hernia repair. Total duration of procedure is 15 minutes. 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  American society of anesthesiology class 1 & 2 patients of either sex from age 18-60 years of age undergoing unilateral inguinal hernia repair will be included in the study.
 
 
ExclusionCriteria 
Details  Patients refusal,Hypersensitivity to local Anaesthesia,Heart Rate less than 60/min,Pregnancy,Body mass index more than 35 kilogram per square metre,contraindications to spinal Anaesthesia. 
 
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 
To compare the duration of postoperative analgesia between the two groups.  0min,3mins,6mins,9mins,12mins,15mins,25mins,35mins,45mins,55mins,1hr,1hr15mins,1hr30mins,1hr45mins,2hrs,4hrs,6hrs,8hrs,10hrs,12hrs,15hrs,18hrs,21hrs,24hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the total tramadol consumption between two different doses of buprenorphine with levobupivacaine   0min,3mins,6mins,9mins,12mins,15mins,25mins,35mins,45mins,55mins,1hr,1hr15mins,1hr30mins,1hr45mins,2hrs,4hrs,6hrs,8hrs,10hrs,12hrs,15hrs,18hrs,21hrs,24hrs 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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 1 
Date of First Enrollment (India)   24/06/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 [Sriramakrishnan247@gmail.com].

  6. For how long will this data be available start date provided 24-06-2024 and end date provided 24-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Post operative analgesia is a challenge in patients undergoing inguinal hernia repair. An ideal Post operative analgesic technique must be effective in repressing the pain in hernia surgeries with no or minimal side effects to the patient. While subarachnoid block is a commonly performed anaesthesia technique for inguinal hernia surgeries it’s actions are limited. Most patients report moderate to severe intensity of pain affecting overall quality of life soon after the surgery. This study aims to compare abdominal plane blocks that will be administered for post-operative analgesia to the patients and to understand which will act for a longer duration. 
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