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CTRI Number  CTRI/2023/10/058865 [Registered on: 19/10/2023] Trial Registered Prospectively
Last Modified On: 18/10/2023
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 of Onset, duration, quality of postoperative analgesia of epidurally administered Bupivacaine with Dexmedetomidine group and Bupivacaine with Buprenorphine group. 
Scientific Title of Study   comparative study of dexmedetomidine and buprenorphine as adjuvants to postoperative epidural bupivacine for analgesia in lower limb joint replacement surgeries. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenakshi t 
Designation  pg student anesthesia 
Affiliation  vyditute of medical sciences and research centreehi inst 
Address  Department of anaesthesia, vydehi institute of medical sciences and research centre.
bangalore karnataka
Bangalore
KARNATAKA
560066
India 
Phone  8073744059  
Fax    
Email  mnksh97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sathyanarayan j 
Designation  associate proffessor 
Affiliation  vydehi institute of medical sciences 
Address  department of anesthesia vydehi institute of medical sciences and research centre
Bangalore, karnataka
Bangalore
KARNATAKA
560066
India 
Phone  7204222070  
Fax    
Email  sathyaforall2005@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sathyanarayan j 
Designation  associate proffessor 
Affiliation  vydehi institute of medical sciences 
Address  department of anesthesia vydehi institute of medical sciences and research centre
Bangalore, karnataka
Bangalore
KARNATAKA
560066
India 
Phone  7204222070  
Fax    
Email  sathyaforall2005@gmail.com  
 
Source of Monetary or Material Support  
vydehi institute o medical sciences and research centre, bangalore, karnataka 
 
Primary Sponsor  
Name  vydehi institute of medical sciences 
Address  whitefield, nallurhalli, bengaluru, karnataka, 560066 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 
DrMeenakshi T  Vydehi Institute of Medical sciences And Research centre  Anesthesia Department , !st floor, Operation theatre Complex , Bangalore
Bangalore
KARNATAKA 		 8073744059

mnksh97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VYDEHI INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  bupivacaine with buprenorphine  comparison of onset of analgesia, time taken for relief of pain, duration and quality of post operative analgesia 
Intervention  bupivacaine with dexmedetomidine  comparison of onset of analgesia, time taken for relief of pain, duration and quality of post operative analgesia 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)ASA 1 & 2
2)PATIENTS UNDERGOING TOTAL KNEE AND HIP REPLACEMENT SURGERIES
3)Uneventful intraoperative patients 
 
ExclusionCriteria 
Details  1)ASA 3 & 4
2)ALLERGY TO LOCAL ANESTHETICS, DEXMEDETOMIDINE AND BUPRENORPHINE
3) BLEEDING AND NEUROMUSCULAR DISORDERS 
 
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 and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare onset, duration, quality of postoperative analgesia of epidurally administered bupivacaine with dexmedetomidine and bupivacaine with buorenorphine  To compare onset, duration, quality of postoperative analgesia of epidurally administered bupivacaine with dexmedetomidine and bupivacaine with buorenorphine 
 
Secondary Outcome  
Outcome  TimePoints 
assess and compare the haemodynamic parameters, side effects and time for ambulation  after giving epidural topup onset of analgesia, sedation, duration of analgesia, haemodynamic parameters, mobilization time 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="63" 
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)   31/10/2023 
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="8"
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 - NO
Brief Summary   epidural anesthesia is the most commonly used technique for providing not only intraoperative surgical anesthesia but also postoperative analgesia in lower abdominal and lower limb surgeries. early postoperative mobilization and rehabilitation with minimally associated pain and discomfort is the most desirable feature in modern orthopedic surgery. epidural analgesia also obtunds cental sensitizationn and pain induced organ dysfunction, leading to improved outcome.   
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