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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  
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 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  
Status 
Not Applicable 
 
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.
 
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