| CTRI Number |
CTRI/2025/11/097507 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Pain control in adults undergoing knee replacement using two types of local anaesthetic injections with clonidine. |
|
Scientific Title of Study
|
Comparative Study Of Ropivacaine Vs Levobupivacaine With Clonidine In Ultrasound Guided Adductor Canal Block For Postoperative Analgesia In 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 |
Taranjot Singh |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India
Faridkot
PUNJAB
151203
India |
| Phone |
7889824320 |
| Fax |
|
| Email |
taranjotkahlon60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Professor and Head |
| Affiliation |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Professor and Head |
| Affiliation |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab 151203 India |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India |
| 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 |
| Taranjot Singh |
Guru Gobind Singh Medical College Hospital |
Department of Anesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India
Faridkot
PUNJAB |
7889824320
taranjotkahlon60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Guru Gobind Singh Medical College |
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 |
| Comparator Agent |
Levobupivacaine |
Participants will receive 20 mL of 0.25% levobupivacaine combined with clonidine (1 mcg/kg) administered as a single-shot, ultrasound-guided adductor canal block (ACB) preoperatively.
This block will provide analgesia until the patient requires rescue analgesia, which marks the end of the intervention duration. |
| Intervention |
Ropivacaine |
Participants will receive 20 mL of 0.25% ropivacaine combined with clonidine (1 mcg/kg) administered as a single-shot, ultrasound-guided adductor canal block (ACB) preoperatively.
This block will provide analgesia until the patient requires rescue analgesia, which marks the end of the intervention duration. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 40 to 75 years of either gender giving written willingness consent.
Patient belonging to American Society of Anaesthesiology class 1 and 2 and scheduled for elective orthopedic Total knee arthroplasty surgeries under spinal Anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients having history of coagulation abnormalities chronic kidney diseases chronic liver diseases
Any history of allergy or contraindication to study drugs
Any contraindication for neuroaxial anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia, measured as the time from completion of the ultrasound-guided adductor canal block to the first request for rescue analgesia ( assessed using NRS pain score) |
Immediately after adductor canal block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative pain scores at rest & on movement using the Numerical Rating Scale (NRS) at 0,2,4,6,8,12, & 24 hours.
Total rescue analgesia consumption in the first 24 hours postoperatively
Incidence of adverse events ( nausea, vomiting, hypotension, bradycardia, block-related complications).
Patient satisfaction score at 24 hours post-block.
|
After every 2hour till 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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 - NO
|
|
Brief Summary
|
Adductor canal block is a regional anaesthesia technique increasingly used for postoperative analgesia in lower limb surgeries Ropivacaine is a long acting amide local anaesthetic agent with less cardiotoxic effect compared to bupivacaine Levobupivacaine show safer pharmacological profile with less cardiac and neurotoxic adverse effects Clonidine is a frequently used adjuvant to local anaesthetic This study aims to determine the efficacy of ropivacaine with clonidine vs levobupivacaine with clonidine for adductor canal block in total knee arthroplasty surgeries for postoperative analgesia |