| CTRI Number |
CTRI/2021/11/038194 [Registered on: 23/11/2021] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Best Motor Sparing Block for Knee Arthroplasty in 2021 |
|
Scientific Title of Study
|
Femoral Triangle vs Adductor canal vs Dual Sub-Sartorial Block - Choosing the Best Motor Sparing Block for Knee Arthroplasty in 2021 (FAD21): prospective double blinded randomised controlled trial |
| Trial Acronym |
FAD-21 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shlok Saxena |
| Designation |
Fellow in Regional Anesthesia |
| Affiliation |
Ganga Medical Centre and Hospital Pvt Ltd |
| Address |
Ot Complex 6th floor B Block Department of Anesthesiology Ganga Medical Centre and Hospitals Pvt Ltd
Ganga Medical Centre and Hospitals Pvt Ltd 313 Mettupalayam Road Saibaba Kovil Coimbatore 641043 Tamil Nadu
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7411642092 |
| Fax |
|
| Email |
drshloksaxena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J Balavenkatasubramanian |
| Designation |
Senior Consultant (Anaesthesiology) and Academic Director |
| Affiliation |
Ganga Medical Centre and Hospital Pvt Ltd |
| Address |
Ot Complex 6th floor B Block Department of Anesthesiology Ganga Medical Centre and Hospitals Pvt Ltd
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9842245757 |
| Fax |
|
| Email |
drbalavenkat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shlok Saxena |
| Designation |
Fellow in Regional Anesthesia |
| Affiliation |
Ganga Medical Centre and Hospital Pvt Ltd |
| Address |
Ot Complex 6th floor B Block Department of Anesthesiology Ganga Medical Centre and Hospitals Pvt Ltd
Ganga Medical Centre and Hospitals Pvt Ltd 313 Mettupalayam Road Saibaba Kovil Coimbatore 641043 Tamil Nadu
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7411642092 |
| Fax |
|
| Email |
drshloksaxena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Centre and Hospitals Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Ganga Medical Centre and Hospitals Pvt Ltd |
| Address |
Ganga Medical Centre and Hospitals Pvt Ltd
313 Mettupalayam Road Saibaba Kovil Coimbatore 641043 Tamil Nadu India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shlok Saxena |
Ganga Medical Centre and Hospitals Pvt Ltd |
OT complex,7th floor B block, Department of Anaesthesiology Ganga Medical Centre and Hospitals Pvt Ltd 313 Mettupalayam Road Saibaba Kovil Coimbatore 641043
Coimbatore
TAMIL NADU |
7411642092
drshloksaxena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ganga Medical Centre & Hospitals Pvt Ltd Institutional Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 7||Osteopathic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adductor canal block |
The adductor canal block will be performed in the proximal adductor canal, identifying the superficial femoral artery(FA) deep to the sartorius muscle(STM) in a short-axis view. After identification of the saphenous nerve(SN), the needle will be advanced in-plane, from lateral to medial or out of plane, until the needle-tip is in the paraneural position. 20ml of Study LA admixture will be deposited anterolateral to the FA following negative aspiration for blood.
Follow up of the patient will be conducted till discharge |
| Intervention |
Dual Subsartorial block |
A combination of proximal adductor canal block and a distal femoral triangle block will be performed - depositing 20 ml of Local Anaesthesia admixture in Femoral Triangle and 10 ml in Proximal adductor canal.
Follow up of the patient will be conducted till discharge |
| Intervention |
Femoral Triangle block |
High-frequency linear ultrasound probe will be placed over the mid-thigh. The anterolateral Vastus medialis muscle(VMM), posteromedial Adductor Longus Muscle(ALM), and medially Sartorius Muscle will be identified. The apex of the femoral triangle will then then identified where the medial border of STM overlies
the medial border of ALM, forming the sign of “3†or “kissing Sign.
After identifying the apex of the FT, an ultrasound probe
will be moved slightly (1-2 cm) proximally.
Below the STM, femoral vessels are identified using color doppler.
The SN nerve lies lateral to the FA and appears as a hyperechoic structure under ultrasound. The NVM will then be identified just lateral to the SN in the intermuscular plane between STM and VMM.
10ml of LA mixture will be injected around it, and another 10 ml of LA mixture will be injected around SN
Follow up of the patient will be conducted till discharge
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled for elective knee arthroplasty
Accepted mental state of the patient
ASA 1 and 2 patients
Unilateral TKR
|
|
| ExclusionCriteria |
| Details |
Patient Refusal
Patients with polytrauma
Infection at the injection site of block
Known allergy to local anaesthetics
Advanced hepatic & renal failure
Chronic opioid consumption
Coagulopathy
Severe valgus deformity
Lateral approach for TKR
Augmented TKR
Revision TKR |
|
|
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 measure post block quadriceps strength |
6 hr, 12 hr, 18 hr, 24 hr, 36 hr, 48 hr, 72 hr and at discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe analgesic efficacy of each block |
Post Block VAS score (0-10) at 30min, 60min, 90min,120 min, 4 hr, 6 hr, 8 hr, 10 hr,12 hr, 18 hr, 24 hr, 36 hr, 48 hr, 72 hr and at Discharge |
| Post Block Opioid (morphine equivalents) Consumption |
post block Opioid (Morphine equivalents) consumption till discharge
|
| Patient Satisfaction score |
1- Unsatisfied, 2- Satisfied, 3- Fully Satisfied at POD 0 till Discharge
|
| Active knee extension |
knee extension in degrees 0,15,30,45,90 at 6 hr,12 hr,18 hr,24 hr,36 hr,48 hr,72 hr and at Discharge |
| Quality of Sonoimage |
Best/Average/Poor |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "135"
Final Enrollment numbers achieved (India)="135" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2021 |
| Date of Study Completion (India) |
15/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/12/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published
https://www.cureus.com/articles/396194-pursuing-an-optimal-regional-analgesia-strategy-for-total-knee-arthroplasty-a-double-blind-randomized-controlled-study-of-femoral-triangle-adductor-canal-and-dual-subsartorial-blocks-fad-trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post-operative pain associated with Total knee arthroplasty has challenged the regional anaesthetists to find better alterative to opioids to improve the patient experience by minimizing the ill-effects of opioids. With the recent introduction of ERAs, the limitations of muscle weakness associated with conventional nerve blocks for TKR was faced with criticism. The description of motor sparing blocks led to the introduction of multiple blocks. However, no one block has yet been described which has been able to provide the comfort associated with the conventional techniques. Adductor canal block(ACB) and Femoral triangle(FT) blocks are the widely practised motor sparing blocks as part of ERAs protocol. Dual sub sartorial block(DSB) is a recently described block which has been found to be a promising procedure specific block. |