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CTRI Number  CTRI/2017/10/010081 [Registered on: 12/10/2017] Trial Registered Prospectively
Last Modified On: 12/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   addition of two different drugs Buprenorphine or Dexamethasone to Levobupivacaine in TAP block may or may not provide better pain control in inguinal hernia repair  
Scientific Title of Study   "Effect of addition of Buprenorphine or Dexamethasone to Levobupivacaine on postoperative analgesia in ultrasound guided Transversus Abdominis Plane block for Inguinal hernia repair: A prospective double blind randomized control trial" 
Trial Acronym  TAP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satya narayan seervi 
Designation  Junior Resident 
Affiliation  Dr. S.N.medical collage and attached hospital, Jodhpur 
Address  Department Of Anaesthesiology And Critical Care, Dr.S.N.Medical College Jodhpur.
Room no. 226,new PG hostel, MDM hospital campus,shastri nagar,jodhpur,rajasthan.
Jodhpur
RAJASTHAN
342003
India 
Phone  7737658824  
Fax    
Email  drsatyanarayanseervi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Satya narayan seervi 
Designation  Junior Resident 
Affiliation  Dr. S.N.medical collage and attached hospital, Jodhpur 
Address  Department Of Anaesthesiology And Critical Care, Dr.S.N.Medical College Jodhpur.
Room no. 226,new PG hostel, MDM hospital campus,shastri nagar,jodhpur,rajasthan.
Jodhpur
RAJASTHAN
342003
India 
Phone  7737658824  
Fax    
Email  drsatyanarayanseervi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geeta singariya 
Designation  Professor, Department of anaesthesia, Dr S.N.medical collage Jodhpur 
Affiliation   
Address  Department Of Anaesthesiology And Critical Care, Dr.S.N.Medical College Jodhpur.

Jodhpur
RAJASTHAN
342003
India 
Phone  9414803554  
Fax    
Email  geetamanoj007@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr. S.N. Medical College, Jodhpur  
 
Primary Sponsor  
Name  Dr S N medical collage and attached hospital Jodhpur 
Address  Shastri nagar jodhpur rajasthan. 
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 Satya narayan seervi  MDM hospital  Operation theatre complex,Department of Anaesthesiology and critical care Jodhpur.
Jodhpur
RAJASTHAN 		 7737658824

drsatyanarayanseervi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.S.N.edical College Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA grade 1 and 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Buprenorphine  GROUP LB: Patient will receive 20 ml 0.25% inj. levobupivacaine + 1 ml inj. buprenorphine (.3mg/ml) with total volume of 21 ml. 
Intervention  Dexamethasone  GROUP LD: Patient will receive 20 ml 0.25% inj. levobupivacaine + 1 ml inj. dexamethasone (4mg/ml) with total volume of 21 ml. 
Comparator Agent  no any adjuvant  GROUP L: Patient will receive 20 ml 0.25% inj. levobupivacaine + 1 ml normal saline with total volume of 21 ml. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age group of 18 –60 years of both sex
2. ASA grade I and II
3. Weight 50-100 kg
4. Patients undergoing surgery for unilateral inguinal hernia repair
 
 
ExclusionCriteria 
Details  1. Patient’s or relative’s refusal
2. Known hypersensitivity to local anesthetics
3. Opioid addicts
4. Any chronic systemic illness
5. Bleeding diasthesis
6. Anatomical abnormality
7. Any infection at the regional site
8. Pregnant women
9. Pre existing peripheral neuropathy or neurological deficits

 
 
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 post operative pain score (NRS).
Duration of analgesia.
To compare post operative rescue analgesic (inj.tramadol) requirment.
 		 24 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
•To compare the hemodynamic and respiratory parameters.  24 hours 
•Patient’s satisfaction.  24 hours 
•Any side effects or complications of study drugs and block.  24 hours 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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)   16/10/2017 
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="4"
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)?  

Brief Summary       This is a prospective randomized double blind study. The institutional ethical committee clearance obtained and informed consent would be taken from patient. The total 93 patients of age between 18-60 years, ASA Grade 1 and 2 undergoing unilateral inguinal hernioplasty would be randomly divided in three groups of 31 each. After surgery under spinal anaesthesia group L will receive 20ml 0.25% levobupivacaine + 1 ml NS, group LB will receive 20ml 0.25% levobupivacaine + 0.3mg buprenorphine and group LD will receive 20ml 0.25% levobupivacaine + 4mg dexamethasone, total 21ml in each ultrasound guided TAP block. Postoperatively we will record and compare the duration of analgesia, total rescue analgesic (tramadol) consumption and NRS pain score in first 24 hrs.  
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