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CTRI Number  CTRI/2016/12/007577 [Registered on: 14/12/2016] Trial Registered Retrospectively
Last Modified On: 19/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of epidural analgesia with transversus abdominis plane block in renal transplant recipients 
Scientific Title of Study   Comparison of analgesic efficacy of epidural analgesia with continuous transversus abdominis plane block in renal transplant recipients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hemant Ojha 
Designation  Junior Resident 
Affiliation  Postgraduate Institue of Medical Education and Research 
Address  517, Kairon Block, Postgraduate Institue of Medical Education and Research
Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  0819592155  
Fax    
Email  hemantojha@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ishwar Bhukal 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Aneasthesia & Intensive Care Postgraduate Institue of Medical Education and Research
Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  09417936566  
Fax    
Email  ishwar.bhukal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Hemant Ojha 
Designation  Junior Resident 
Affiliation  Postgraduate Institue of Medical Education and Research  
Address  517, Kairon Block, Postgraduate Institue of Medical Education and Research (PGIMER)
Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  0819592155  
Fax    
Email  hemantojha@hotmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh 
 
Primary Sponsor  
Name  PGIMER 
Address  Sector 12, Chandigarh 
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 HEMANT OJHA  Postgraduate Institute of Medical Education and Research  Department Renal Transplant Surgery, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH 		 8195921555

hemantojha@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, Postgraduate Institute of Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  End stage renal disease, (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Continuous epidural block  Thoracic epidural with a catheter for continuous analgesia 
Intervention  Continuous transversus abdominis plane block  Ultasound guided transversus abdominis plane block with insertion of catheter for continuous analgesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with end stage renal disease scheduled to undergo live donor renal transplant 
 
ExclusionCriteria 
Details  1.Refusal to give consent.
2.Derangements of coagulation profile contraindicating the use of epidural anaesthesia (INR of ≥1.3 will be considered a cut-off for the study).
3. Addiction to opioids, or alcohol, or history of any other substance abuse.
4.Allergy to local anaesthetic drugs.
5.Extension of surgical incision lateral to anterior axillary line or above T8 dermatome.
6.Inability to communicate (e.g. known psychiatric disorders).
7.Accidental complications such as dural puncture or peritoneal breach.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical Pain rating scale score postoperatively  Numerical Pain rating scale score at 0, 1, 2, 4, 6, 12, 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of postoperative opioid (fentanyl) in the first 24 hours postoperatively  24 hours postoperatively 
Patient satisfaction with the analgesia regimen.  24 hours postoperatively 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2014 
Date of Study Completion (India) 30/11/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Although continuous TAP block has been compared with epidural analgesia in laparoscopic surgeries, to the best of our knowledge a study directly comparing the technique with epidural analgesia has not been performed in renal transplant recipients. The existing study was designed to directly compare continuous TAP block with continuous patient controlled epidural blockade to determine whether TAP block can provide a useful alternative to epidural analgesia in this subset of patients.

The study hypothesizes that transversus abdominis plane block is a non inferior analgesic technique to continuous epidural analgesia in renal transplant recipients.

 
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