| CTRI Number |
CTRI/2025/11/097126 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Local Anesthetic Techniques for Reducing Pain After Knee Replacement Surgery |
|
Scientific Title of Study
|
Comparison Of Femoral Block Using 0.2 percent Ropivacaine And Adductor Canal Block Using 0.5 percent Ropivacaine For Post-Operative Analgesia In Total Knee Replacement Surgeries- A Prospective Observational Study |
| 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 Naik Amey Subhash |
| Designation |
Junior Resident |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Medical Academy, P.O. Nithyanandanagar, Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9637421313 |
| Fax |
|
| Email |
ameynaik97.an@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ananda Bangera |
| Designation |
Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Medical Academy, P.O. Nithyanandanagar, Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9845278880 |
| Fax |
|
| Email |
anandabangera@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Naik Amey Subhash |
| Designation |
Junior Resident |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Medical Academy, P.O. Nithyanandanagar, Mangalore Green Hill Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9637421313 |
| Fax |
|
| Email |
ameynaik97.an@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy, Mangalore, Dakshina Kannada, Karnataka, India Pin Code 575018 |
| NIL |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Medical Academy, P.O. Nithyanandanagar, Mangalore, Dakshina Kannada, Karnataka 575018 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naik Amey Subhash |
K S Hegde Medical Academy |
Department of Anaesthesiology and Critical Care, K S Hegde Medical Academy, P.O. Nithyanandanagar, Mangalore Dakshina Kannada KARNATAKA |
9637421313
ameynaik97.an@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, K S Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adductor Canal Block |
15 ml of 0.2% Ropivacaine with 2% Lignocaine with Adrenaline plus 4mg Dexamethasone given under USG guidance after identifying adductor canal immediately after surgery is complete |
| Comparator Agent |
Femoral Nerve Block |
15 ml of 0.5% Ropivacaine with 10ml of 2% Lignocaine with Adrenaline plus 4mg Dexamethasone given under USG guidance perineurally immediately after surgery is complete |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing unilateral total knee replacement
2. American Society of Anaesthesiologists Physical status 1 to 3
3. BMI between18-35kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Patients with [re-existing neurological deficits
2. Patients with lower limb surgery in past one year
3. Patients with regular consumption of strong opioids and steroids
4.Patients with allergy to Ropivacaine, Lignocaine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain scores using Visual Analogue Scores at rest and on movement at knee joint |
At baseline, 0 hours, 6 hours, 24 hours, 48 hours, 120 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion at knee joint and walking distance |
At 24 hours, 48 hours, 120 hours |
| First instance of rescue analgesic and total cumulative dose of rescue analgesics |
At 120 hours |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
01/12/2025 |
| 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="3" 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
|
During the pre-anaesthetic evaluation, the patients fitting the inclusion criteria will be given a baseline Visual Analogue Scale (VAS) to record baseline pain levels. The patients receiving femoral nerve block with 0.2% ropivacaine will be placed in group F and the patients receiving adductor canal block with 0.5% ropivacaine will be placed in group A. The patients will receive the respective blocks postoperatively under USG guidance, either in the operation theatre or in the post anaesthesia care unit. Standard techniques as described ahead shall be followed for each patient at the hands of an experienced anaesthesiologist. For the femoral nerve block group The transducer will be placed transversely at the inguinal crease, and the femoral vessels will be located. If multiple arteries are present (i.e., superficial and deep femoral arteries), then the probe will be slid proximally until only the common femoral artery is visualized along with its associated femoral vein. Immediately lateral to the femoral vessels, the femoral nerve classically appearing as a hyperechoic wedge or ovoid structure will be identified. Once the femoral nerve and relevant neighbouring structures have been identified, a 2% Lignocaine wheal will be administered before the block needle insertion into the tissue, and the needle tip is advanced below the fascia iliaca towards the femoral nerve Confirming negative aspiration for blood, a mixture of 15ml of 0.2% ropivacaine plus 10 ml of 2% lignocaine with adrenaline and 1ml (4mg) dexamethasone will be injected with the ultrasound monitor showing the spreading of the drug around the nerve For adductor canal block The transducer will be placed anteromedially, approximately at the junction between the middle and distal third of the thigh. If the artery is not immediately obvious, several manoeuvres will be used to identify it, including colour Doppler scanning to trace the femoral artery caudally from the inguinal crease. Once the femoral artery has been identified, the probe will be moved distally to trace the artery until it passes through the adductor hiatus to become the popliteal artery. Adductor canal nerve block will be performed more proximally, around the mid-thigh level. The needle will be inserted in-plane in a lateral-to-medial orientation and advanced toward the femoral artery, after a 2% lignocaine wheal will be raised at site of injection. 15 ml of the respective concentration of Ropivacaine and 10 ml of 2% Lignocaine with Adrenaline with 1ml of Dexamethasone (4mg). Maximum pain score using VAS will be recorded in the Post-anaesthesia Care Unit (PACU) and in wards at 0, 24, 48, and 120 h after surgery. Pain scores using VAS at rest and at movement will be recorded at 24, 48, and 120 h post-surgery. Patients’ satisfaction will be scored on a scale of 0 to 10, which indicates absolutely no satisfaction to absolute satisfaction at 24, 48, and 120 h post-surgery. Mobilization, walking distance, and range of knee motion with maximum knee extension in degrees and maximum flexion in degrees will be entered in the database at 24, 48, and 120 h post-surgery. In the period of 120h, if the pain score exceeds 4/10 rescue analgesia in the form of Injection Paracetamol 1g iv shall be given. If pain scores fail to improve despite Injection Paracetamol, Injection tramadol 50mg slow in 100cc normal saline with slow Injection Ondansetron 4mg shall be given. Total cumulative dose of rescue analgesic as well as the earliest point of time when rescue analgesic was needed will be recorded. |