| CTRI Number |
CTRI/2025/08/093605 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| 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
|
Comparing the drugs to get better pain management |
|
Scientific Title of Study
|
A Prospective randomized comparative study evaluating the analgesic efficacy of 0.2% Ropivacaine versus 0.2% Ropivacaine with dexmedetomidine in adductor canal block combined with iPACK for total knee arthroplasty |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRAVEEN RAJU |
| Designation |
Postgraduate in Department of ANAESTHESIOLOGY |
| Affiliation |
Ballari Medical college and Research centre |
| Address |
Postgraduate in MD anaesthesia BMCRC
Room no 30 new boys pg hostel
Department of Anaesthesiology Ballari Medical college and Research centre
Vijaya Nagar
Cantonment
Ballari Karnataka 583104
Postgraduate in MD anaesthesia BMCRC
Room no 30 new boys pg hostel
Department of Anaesthesiology Ballari Medical college and Research centre
Vijaya Nagar
Cantonment
Ballari Karnataka 583104
Bellary
KARNATAKA
583104
India |
| Phone |
8838206011 |
| Fax |
|
| Email |
dr.praveenvenkat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghunath |
| Designation |
Associate Professor |
| Affiliation |
Ballari Medical college and Research centre |
| Address |
Assosciate professor in Department of Anaesthesiology Ballari Medical college and Research centre
Department of Anaesthesiology
Vijaya Nagar
Cantonment
Ballari Karnataka 583104
Bellary
KARNATAKA
583104
India |
| Phone |
9945434495 |
| Fax |
|
| Email |
docraghu2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Raju |
| Designation |
Postgraduate in MD anaesthesia BMCRC |
| Affiliation |
Ballari Medical college and Research centre |
| Address |
Postgraduate in MD anaesthesia Room no 30 new boys pg hostel
Ballari Medical college and Research centre
Department of ANAESTHESIOLOGY
Vijaya Nagar
Cantonment
Ballari Karnataka 583104
Bellary
KARNATAKA
583104
India |
| Phone |
8838206011 |
| Fax |
|
| Email |
dr.praveenvenkat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
BALLARI MEDICAL COLLEGE AND RESEARCH CENTRE
Vijaya Nagar
Cantonment Ballari
Karnataka
India
583104
|
|
|
Primary Sponsor
|
| Name |
Ballari Medical college and Research centre |
| Address |
Vijaya Nagar, Cantonment, Ballari, Karnataka 583104 |
| 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 Praveen Raju |
Ballari medical college and Research centre |
Vijaya Nagar
Cantonment
Ballari
Karnataka
583104
Bellary
KARNATAKA |
8838206011
dr.praveenvenkat@gmail.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: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparative study to evaluate analgesic efficacy by adding dexmeditomidate to inj Ropivacaine 0.2% in adductor canal block with ipack for total knee arthroplasty |
Adductor canal block 20ml of 0.2% Ropivacaine and iPACK 20ml of 0.2%Ropivacaine injected to block saphenous nerve and tibal and common peroneal nerve through USG guided |
| Comparator Agent |
Comparative study to evaluate analgesic efficacy by adding dexmeditomidate to inj Ropivacaine 0.2% in adductor canal block with ipack for total knee arthroplasty |
Adductor canal block with 20ml and iPACK Block with 20ml of 0.2% Ropivacaine and Dexmeditomidate 1mcg/kg will be given thorough USG guided in adductor canal block around saphenous nerve and iPACK block around common peroneal nerve and tibial nerve |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 25-80 years
ASA physical status I–III
Undergoing elective total knee replacement surgeries
Willingness to participate with informed consent
|
|
| ExclusionCriteria |
| Details |
Patient refusal to the study
BMI morethan 40
Revision or bilateral knee surgeries
Known allergy to local anaesthetics
Neurological disorders affecting lower limb mobility
Coagulopathy or on anticoagulants
Patients refusing regional anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia |
Duration of Analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative pain scores using the NRS at rest & during movement at 2 4 6 12 24 36 & 48 hours
Time of activation of first epidural as rescue analgesic
Degree of motor blockade (Modified Bromage Scale)
Ramsay sedation score
Time to first ambulation
Patient satisfaction score
Incidence of side effects or complications eg hypotension urinary retention nausea vomiting motor weakness
|
2hours,4hours, 6hours, 12hours, 24hours, 36hours,& 48 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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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 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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.praveenvenkat@gmail.com].
- For how long will this data be available start date provided 01-05-2025 and end date provided 30-11-2026?
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
|
This is a prospective randomized comparative interventional study designed to evaluate the analgesic efficacy of 0.2percentageropivacaine alone versus 0.2 percentage ropivacaine combined with dexmedetomidine when used in adductor canal block combined with iPACK infiltration between the popliteal artery and capsule of the knee for postoperative analgesia in patients undergoing total knee arthroplasty TKA Patients undergoing unilateral TKA will be randomly assigned to one of two groups
Group R Receiving 0.2percentage ropivacaine
Group RD Receiving 0.2 percentage ropivacaine with dexmedetomidine
Both groups will receive the block as part of a multimodal analgesic regimen The primary outcome is to compare the duration and quality of postoperative analgesia between the two groups Secondary outcomes include opioid consumption pain scores patient satisfaction and incidence of adverse effects
This study aims to determine whether the addition of dexmedetomidine enhances the analgesic effect of ropivacaine in regional nerve blocks for knee arthroplasty potentially improving pain control and functional recovery |