| CTRI Number |
CTRI/2025/09/094356 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| 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
|
Comparison of Two Nerve Block Techniques for Pain Relief After Total Knee Replacement Surgery |
|
Scientific Title of Study
|
A Comparison Between Adductor Canal Block and Femoral Nerve Block for Postoperative Analgesia in Patients Undergoing Total Knee Replacement |
| 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 Aakash Kasana |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesia, Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS) |
| Address |
Department of Anaesthesia Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS)
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
8527059539 |
| Fax |
|
| Email |
kasanaaakash63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Karki |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Anaesthesia, Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS) |
| Address |
Department of Anaesthesia Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS)
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
8193980882 |
| Fax |
|
| Email |
krkgits@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Karki |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Anaesthesia, Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS) |
| Address |
Department of Anaesthesia Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS)
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
8193980882 |
| Fax |
|
| Email |
krkgits@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ram Murti Smarak Institute of Medical Sciences, Bhojipura, Bareilly, Uttar Pradesh- 243202 |
|
|
Primary Sponsor
|
| Name |
SRMS IMS |
| Address |
Ram Murti Puram, 13 KM, Bareilly - Nainital Rd, Bhojipura, Abheypur Keshonpur, Uttar Pradesh 243202 |
| Type of Sponsor |
Private 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 Aakash Kasana |
Shri Ram Murti Smarak Institute of Medical Sciences Hospital |
OT Complex second floor, Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences
Bareilly
UTTAR PRADESH |
8527059539
kasanaaakash63@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 |
| Healthy Human Volunteers |
ELECTIVE SURGERIES FOR ASA GRADE I/II/III |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adductor Canal Block |
After completion of surgery under spinal anaesthesia, patients in this group will receive an ultrasound-guided adductor canal block. The patient will be kept in supine position with thigh abducted and externally rotated. Using USG guidance, the femoral artery will be identified beneath the sartorius muscle. 0.5% Bupivacaine, 20 mL will be injected in the adductor canal after confirming negative aspiration. This will be given for postoperative analgesia following total knee replacement. |
| Comparator Agent |
Femoral Nerve Block |
After completion of surgery under spinal anaesthesia, patients in this group will receive an ultrasound-guided femoral nerve block. The patient will be kept in supine position and the transducer placed at the femoral crease in the inguinal area. The femoral artery will be identified, and the needle advanced below the fascia iliaca near the femoral nerve. 0.5% Bupivacaine, 20 mL will be injected after confirming negative aspiration. This will be given for postoperative analgesia following total knee replacement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-70 years of either sex
ASA physical status I/II/III |
|
| ExclusionCriteria |
| Details |
ASA physical status IV
Contraindications to spinal anaesthesia
Pregnancy
Major psychiatric diseases and history of substance abuse
Hypersensitivity to study drug- Bupivacaine hydrochloride 0.5%
Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare visual analogue scale (VAS) scores at different period of time in postoperative period between Adductor canal block group and Femoral nerve block group.
To compare range of motion in knee joint as angle of flexion upto 48 hours in the two groups |
The patients will be assessed for pain using visual analogue scale (VAS) score and mobility by observing the angle of flexion of knee joint at 1, 2, 3, 6, 12, 24 and 48 hours in the postoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare opioid consumption in the two groups in first 48 hours
To compare degree of patient satisfaction between the two groups |
The patients will also be compared in the two groups based on the opioid consumption in first 48 hours along with the degree of patient satisfaction at the end of the study using an ordinal scale (e.g., very satisfied, somewhat satisfied, dissatisfied, very dissatisfied) |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
10/08/2027 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Knee replacement surgery is often followed by significant pain, which can slow recovery and limit early movement. Nerve blocks are commonly used to reduce this pain. The Femoral Nerve Block has been used for many years but may cause weakness in the thigh muscles, affecting walking after surgery. The Adductor Canal Block is a newer method that provides good pain relief while better preserving muscle strength.
This study aims to compare these two techniques in patients undergoing knee replacement surgery. The objective is to find out which block gives better pain relief, fewer side effects, and faster return of mobility after the operation.
|