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CTRI Number  CTRI/2021/02/031366 [Registered on: 17/02/2021] Trial Registered Prospectively
Last Modified On: 05/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study between ropivacaine and dexmedetomidine vs levobupivacaine and dexmedetomidine in post operative analgesia in adductor canal block. 
Scientific Title of Study   A Comparative study between ropivacaine and dexmedetomidine vs levobupivacaine and dexmedetomidine for post-operative analgesia using adductor canal block in patients undergoing total knee replacement surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Col Vivek Bharti Sharma 
Designation  Associate Professor 
Affiliation  Army Hospital(Research and Referral) 
Address  Dept of Anaesthesiology and critical care, Second floor, B Wing, Army Hospital Research and Referral
Dhaula kuan, Delhi Cantt, New Delhi
South
DELHI
110010
India 
Phone  9596899737  
Fax    
Email  vrkysvrky@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Col Vivek Bharti Sharma 
Designation  Associate Professor 
Affiliation  Army Hospital(Research and Referral) 
Address  Dept of Anaesthesiology and critical care, Second floor, B Wing, Army Hospital Research and Referral
Dhaula kuan, Delhi Cantt, New Delhi
South
DELHI
110010
India 
Phone  9596899737  
Fax    
Email  vrkysvrky@gmail.com  
 
Details of Contact Person
Public Query  
Name  Maj Manzoor Ali 
Designation  Junior Resident 
Affiliation  Army Hospital Research and Referral  
Address  Dept of Anaesthesiology and critical care, Second floor, B Wing, Army Hospital Research and Referral
Dhaula kuan, delhi cantt, New Delhi-110059
South
DELHI
110059
India 
Phone  09599779873  
Fax    
Email  drmanzoorali54@gmail.com  
 
Source of Monetary or Material Support  
Government 
 
Primary Sponsor  
Name  Army Hospital Research and Referral 
Address  Dhaula kuan, Delhi Cantt, New Delhi-110010 
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 
Manzoor Ali  Army Hospital Research and Referral  Department of Anaesthesiology and critical care, Second Floor, B Wing, Dhaula kuan, Delhi Cantt, New delhi-110059
South
DELHI 		 9599779873

drmanzoorali54@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee Army Hospital Research and Referral  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparison between ropivacaine and dexmedetomidine vs levobupivacaine and dexmedetomidine in post operative analgesia.  A COMPARATIVE STUDY BETWEEN ROPIVACAINE AND DEXMEDETOMIDINE VS LEVOBUPIVACAINE AND DEXMEDETOMIDINE IN POST-OPERATIVE ANALGESIA ULTRASOUND GUIDED ADDUCTOR CANAL BLOCK IN PATIENTS UNDERGOING TOTAL KNEE REPLACEMENT SURGERIES. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Age 30-75 yrs.
2.American society of anestheiologists(ASA) grade I- III.
3.Written Informed Consent for the procedure. 
 
ExclusionCriteria 
Details  1.American society of anestheiologists(ASA) grade 1V.
2.Age <30 and >75 yrsPatients with BMI > 30 Kg/m2 .
3.Patient refusing block.
4.Patients with known allergies to the study drugs.
5.Patient with history of psychiatric disease on psychotropic medication.
6.History of medical conditions like, bleeding diatheses and local skin site infection.
7.History of alcohol or drug abuse
8.Uncooperative patient. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Time to first demand of rescue analgesia
2.Duration of analgesia
3.Rescue analgesic consumption (total in 24 hrs). 		 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.Onset and duration of motor block (if any).
2.Patient satisfaction score on a numeric scale (0-10 ‘0’ being not
satisfied and ‘10’ being satisfied).
3.Incidence of complications. 		 24 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/03/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 [drmanzoorali54@gmail.com].

  6. For how long will this data be available start date provided 01-06-2021 and end date provided 27-06-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
1.All patients undergoing surgery will be explained about study and informed written duly signed consent will be taken.
2.Patient will be randomly allocated to Group R(0.375% Ropivacaine + Dexmedetomidine 0.5 mcg/kg) or Group L ( 0.25% Levobupivacine + Dexmedetomidine 0.5 mcg/kg) consisting of 30 patients each.
3.After conclusion of the unilateral knee replacement surgery, patients will be monitored for  HR,NIBP, ECG and SpO2  prior to block.
4.After proper positioning  Adductor Canal will be identified using Ultrasound and 20ml of drug will be injected in the canal. The plane of drug spread between sartorius and the femoral artery will be seen real time on ultrasound.
5.The patients will be observed for 60 min post procedure in the post anaesthesia recovery room. HR,NIBP and SpO2 will be monitored continuously and noted at 15 min interval for the 1st hour after the block and then 2 hourly for 24 hrs and response of VAS (0-10) for post-operative analgesia will be recorded.
6.Inj Tramadol (1.5mg/kg) will be used as first rescue analgesia and time duration for its demand and total consumption of tramadol, diclofenac and paracetamol in 24 hours postoperatively will be noted.
7.Overall satisfaction score of patient will be recorded on a scale of 1-10.

 
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