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
|
|
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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response (Others) - study protocol
statistical analysis plan
- Who will be able to view these files?
Response (Others) - anyone
- For what types of analyses will this data be available?
Response (Others) - to achieve aims in the approved proposal
- By what mechanism will data be made available?
Response - Proposals should be directed to [nandakishore645@gmail.com].
- 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.
- 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. |