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CTRI Number  CTRI/2024/04/066191 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of postoperative analgesia in patients undergoing hip surgeries with ultrasound guided fascia iliaca block using different local anaesthetics combination  
Scientific Title of Study   To compare the efficacy of clonidine and dexmedetomidine as adjuvants to ropivacaine for postoperative analgesia in ultrasound guided suprainguinal fascia iliaca compartment block for patients undergoing elective hip 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  Dr Nandakishore B R  
Designation  Post Graduate 
Affiliation  Chamarajanagar Institute of Medical Sciences  
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India

Chamarajanagar
KARNATAKA
571313
India 
Phone  8951316291  
Fax    
Email  nandakishore645@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Darshan M S  
Designation  Head of Department  
Affiliation  Chamarajanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India

Chamarajanagar
KARNATAKA
571313
India 
Phone  9741376797  
Fax    
Email  darshanms_jss@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nandakishore B R  
Designation  Post Graduate 
Affiliation  Chamarajanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India

Chamarajanagar
KARNATAKA
571313
India 
Phone  8951316291  
Fax    
Email  nandakishore645@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology 4th floor, Chamarajanagar Institute of Medical Sciences Yadapura Chamarajanagar 571313 
 
Primary Sponsor  
Name  Chamarajanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar 
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 DARSHAN MS  Chamarajanagar Institute of Medical Sciences Chamarajanaga  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar
Chamarajanagar
KARNATAKA 
09741376797

darshanms_jss@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  Injection Clonidine 0.1mcg/kg  Injection Clonidine 0.1mcg/kg added to Injection Ropivacaine 0.2% 40 ml as single dose in interfascial plane.  
Comparator Agent  Injection Dexmedetomidine 0.1mcg/kg   Injection Dexmedetomidine 0.1mcg/kg added to Injection Ropivacaine 0.2% 40 ml as single dose in interfascial plane 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient accepting to participate with written informed consent.
Patients belonging to ASA with physical status grade 1 and 2 of either sex.
Patient with age group between 18 to 70 years posted for elective major hip surgeries. 
 
ExclusionCriteria 
Details  Patient allergic to study drug or hypersensitivity to local anesthetics.
Patient with cardiac disease, hepatic disease, renal disease, hypothyroidism, neuropathy, local site infection, bleeding diathesis, COPD, Obstructive sleep aponea .
Patient on beta blockers, bradycardia (heart rate <60bpm).
Patient with BMI >30 kg/m2. 
 
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 
Pain scores will be assessed as per visual analogue scale and the time needed for rescue analgesia  assessed over 24 hours every 5 minutes for first half an hour followed by every 2 hours for next 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
a) To study hemodynamic changes between two groups of patients.

b) To assess the sedation among two groups of patients. 
24 hours 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 4 
Date of First Enrollment (India)   09/05/2024 
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="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 (Others) -  study protocol statistical analysis plan
  3. Who will be able to view these files?
    Response (Others) -  anyone

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

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nandakishore645@gmail.com].

  6. For how long will this data be available start date provided 18-12-2023 and end date provided 31-03-2026?
    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  

 Most of the patients undergoing hip surgeries belong to geriatric age group and have multiple co morbidities and in whom providing effective analgesia is challenging. Since suprainguinal fascia iliaca compartment block is proposed to have prolonged analgesic effect and reduces the need of opiods which hasten the early mobilization, recovery and reduced hospital stay. Since there are a few studies on suprainguinal fascia iliaca compartment block the present study is being done to assess the efficacy in using adjuvants in suprainguinal fascia iliaca compartment block. The block is performed using ropivacaine 0.2% with adjuvants clonidine and dexmedetomidine to check for the efficacy of these drugs in prolongation of postoperative analgesia for hip surgeries. 

 
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