FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/10/037439 [Registered on: 21/10/2021] Trial Registered Prospectively
Last Modified On: 20/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of pain relief after total knee replacement surgery between Levobupivacaine(local anaesthetic drug) alone versus Levobupivacaine with Dexmedetomedine(additive) 
Scientific Title of Study   Ultrasound guided continuous adductor canal block for postoperative pain relief after total knee arthroplasty with levobupivacaine versus levobupivacaine with dexmedetomidine- A randomized Clinical study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KISHORE KEERTHY N 
Designation  ASSISTANT PROFESSOR 
Affiliation  KIMS MEDICAL COLLEGE,BANGALORE 
Address  MAJOR OT COMPLEX,DEPARTMENT OF ANAESTHESIA,4TH FLOOR,A BLOCK,KIMS HOSPITAL,VV PURAM,BANGALORE

Bangalore
KARNATAKA
560059
India 
Phone  9739083518  
Fax    
Email  drkishorekeerthy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  KISHORE KEERTHY N 
Designation  ASSISTANT PROFESSOR 
Affiliation  KIMS MEDICAL COLLEGE,BANGALORE 
Address  MAJOR OT COMPLEX,DEPARTMENT OF ANAESTHESIA,4TH FLOOR,A BLOCK,KIMS HOSPITAL,VV PURAM,BANGALORE

Bangalore
KARNATAKA
560059
India 
Phone  9739083518  
Fax    
Email  drkishorekeerthy@gmail.com  
 
Details of Contact Person
Public Query  
Name  KISHORE KEERTHY N 
Designation  ASSISTANT PROFESSOR 
Affiliation  KIMS MEDICAL COLLEGE,BANGALORE 
Address  MAJOR OT COMPLEX,DEPARTMENT OF ANAESTHESIA,4TH FLOOR,A BLOCK,KIMS HOSPITAL,VV PURAM,BANGALORE

Bangalore
KARNATAKA
560059
India 
Phone  9739083518  
Fax    
Email  drkishorekeerthy@gmail.com  
 
Source of Monetary or Material Support  
KIMS MEDICAL COLLEGE AND RESEARCH INSTITUTE,BANGALORE 
 
Primary Sponsor  
Name  KIMS MEDICAL COLLEGE 
Address  KIMS MEDICAL COLLEGE AND RESEARCH INSTITUTE,VV PURAM,BANGALORE 560004 
Type of Sponsor  Private 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 
KISHORE KEERTHY N  KIMS HOSPITAL  DEPARTMENT OF ANAESTHESIA,MAJOR OT COMPLEX,4TH FLOOR A BLOCK,KIMS HOSPITAL,VV PURAM,BANGALORE 560004
Bangalore
KARNATAKA 		 9739083518

drkishorekeerthy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INTITUTIONAL ETHICS COMMITTEE,KIMS BANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  continuous adductor canal block  continuous adductor canal block for post operative pain relief after total knee replacement surgery 
Comparator Agent  Levobupivacaine versus Levobupivacaine with Dexmeditomedine  comparing continuous adductor canal block with Levobupivacaine alone versus Levobupivacaine with Dexmeditomedine for post operative pain relief after total knee replacement. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective TKR surgeries
2. Aged between 18 years and 70 years of age
3. American Society of Anesthesiologists (ASA) class 1 to 3
 
 
ExclusionCriteria 
Details  1. Allergy to local anaesthetic
2. Intellectual impairment or psychiatric condition precluding adequate communication
3. Bleeding disorder, trauma and infection near the procedure area.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
PRIMARY-1.Duration of analgesia.
SECONDARY-1. 24 hour opioid consumption,
2.success of early ambulation,
3.patient satisfaction,
4.Any adverse effects or complications.


 		 24 HOURS
 
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY-1.24 hour opioid consumption,
2.success of early ambulation,
3.patient satisfaction,
4.Any adverse effects or complications.


 		 24 HOURS 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   24/10/2021 
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="0"
Months="3"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drkishorekeerthy@gmail.com].

  6. For how long will this data be available start date provided 28-02-2022 and end date provided 28-02-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomised single blinded parallel group comparative trial.We intend to compare the duration of post operative pain relief,side effects,total additional analgesic requirement following continuous adductor canal block in post operative patients who have undergone single knee total knee replacement.we would like to compare levobupivacaine o.25% alone versus 0.25% Levobupivacaine with Dexmedetomedine 0.5 microgram per kg body weight.this is a single centre study done in India in a private medical college with a sample size of 40 participants in each group. 
Close