| CTRI Number |
CTRI/2024/03/063773 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| 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
|
To compare effect of two different nerve blocks in unilateral total knee replacement |
|
Scientific Title of Study
|
To Evaluate the analgesic efficacy of the anterior femoral cutaneous nerve block (AFCNB) combined with the adductor canal block (ACB) in patients undergoing unilateral total knee replacement (TKR) : A randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vipin Dalal |
| Designation |
Major (Dr) |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt ,New Delhi
New Delhi
DELHI
110010
India |
| Phone |
9416633399 |
| Fax |
|
| Email |
vipindalal786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Josemine Davis |
| Designation |
Colonel (Dr) |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt ,New Delhi
New Delhi
DELHI
110010
India |
| Phone |
9764623542 |
| Fax |
|
| Email |
jose2mine@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Josemine Davis |
| Designation |
Colonel (Dr) |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt ,New Delhi
New Delhi
DELHI
110010
India |
| Phone |
9764623542 |
| Fax |
|
| Email |
jose2mine@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Army Hospital Research and Referral, New Delhi |
|
|
Primary Sponsor
|
| Name |
Josemine Davis |
| Address |
Department of anesthesiology and critical care, army hospital research and referral, new delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Gaurav Purohit |
Department of anesthesiology and critical care, army hospital research and referral, new delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Josemine Davis |
ARMY HOSPITAL RESEARCH AND REFERRAL |
Department of anesthesiology and critical care
New Delhi
DELHI |
9764623542
jose2mine@yahoo.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 |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adductor Canal Block |
Position the patient in a supine position with the leg to be blocked slightly abducted and externally rotated. This exposes the inguinal region and the anterior thigh. Prepare the ultrasound machine and the sterile ultrasound probe cover. Apply sterile gel to the ultrasound probe, and place the probe at the mid-thigh level (midpoint between ASIS and superior part of patella) to visualize the femoral artery and the saphenous nerve within the adductor canal. Using ultrasound, locate the femoral artery and the saphenous nerve within the adductor canal. The femoral artery is pulsatile, and the saphenous nerve is a smaller, non-pulsatile structure located adjacent to the artery. Insert a sterile needle under ultrasound guidance, advancing it in-plane or out-of-plane with the ultrasound probe until it is positioned adjacent to the saphenous nerve within the adductor canal. Aspirate to ensure that the needle is not in a blood vessel. Slowly inject around 20ml of 0.25% of Bupivacaine around the saphenous nerve to provide adequate blockade. The goal is to create a circumferential spread of the anaesthetic around the nerve.
Frequency- once
Route of administration- IM
Total duration - 5-10 minutes |
| Comparator Agent |
Adductor canal block |
Position the patient in a supine position with the leg to be blocked slightly abducted and externally rotated. This exposes the inguinal region and the anterior thigh. Prepare the ultrasound machine and the sterile ultrasound probe cover. Apply sterile gel to the ultrasound probe, and place the probe at the mid-thigh level (midpoint between ASIS and superior part of patella) to visualize the femoral artery and the saphenous nerve within the adductor canal. Using ultrasound, locate the femoral artery and the saphenous nerve within the adductor canal. The femoral artery is pulsatile, and the saphenous nerve is a smaller, non-pulsatile structure located adjacent to the artery. Insert a sterile needle under ultrasound guidance, advancing it in-plane or out-of-plane with the ultrasound probe until it is positioned adjacent to the saphenous nerve within the adductor canal. Aspirate to ensure that the needle is not in a blood vessel. Slowly inject around 20ml of 0.25% of Bupivacaine around the saphenous nerve to provide adequate blockade. The goal is to create a circumferential spread of the anaesthetic around the nerve.
Frequency- once
Route of administration- IM
Total duration - 5-10 minutes |
| Intervention |
Anterior femoral cutaneous nerve block combined with Adductor Canal Block |
Adductor canal block- Position the patient in a supine position with the leg to be blocked slightly abducted and externally rotated. This exposes the inguinal region and the anterior thigh. Prepare the ultrasound machine and the sterile ultrasound probe cover. Apply sterile gel to the ultrasound probe, and place the probe at the mid-thigh level (midpoint between ASIS and superior part of patella) to visualize the femoral artery and the saphenous nerve within the adductor canal. Using ultrasound, locate the femoral artery and the saphenous nerve within the adductor canal. The femoral artery is pulsatile, and the saphenous nerve is a smaller, non-pulsatile structure located adjacent to the artery. Insert a sterile needle under ultrasound guidance, advancing it in-plane or out-of-plane with the ultrasound probe until it is positioned adjacent to the saphenous nerve within the adductor canal. Aspirate to ensure that the needle is not in a blood vessel. Slowly inject around 20ml of 0.25% of Bupivacaine around the saphenous nerve to provide adequate blockade. The goal is to create a circumferential spread of the anaesthetic around the nerve.
Anterior femoral cutaneous nerve block- With the patient in the same position and the USG probe in mid-thigh level (same area as adductor canal block), try to locate the nerves in the plane above the sartorius muscle and fascia lata. Intermediate and Medial branches of femoral nerves (2-3 branches) will be located in this plane. Once the nerve are located, the needle is redirected towards the nerve and 2-3 ml of 0.25% bupivacaine will be injected around the nerves (Total of 10ml) to complete the block.
Frequency- once
Route of administration- IM
Total duration - 5-10 minutes |
| Comparator Agent |
Anterior femoral cutaneous nerve block combined with adductor canal block |
Adductor canal block- Position the patient in a supine position with the leg to be blocked slightly abducted and externally rotated. This exposes the inguinal region and the anterior thigh. Prepare the ultrasound machine and the sterile ultrasound probe cover. Apply sterile gel to the ultrasound probe, and place the probe at the mid-thigh level (midpoint between ASIS and superior part of patella) to visualize the femoral artery and the saphenous nerve within the adductor canal. Using ultrasound, locate the femoral artery and the saphenous nerve within the adductor canal. The femoral artery is pulsatile, and the saphenous nerve is a smaller, non-pulsatile structure located adjacent to the artery. Insert a sterile needle under ultrasound guidance, advancing it in-plane or out-of-plane with the ultrasound probe until it is positioned adjacent to the saphenous nerve within the adductor canal. Aspirate to ensure that the needle is not in a blood vessel. Slowly inject around 20ml of 0.25% of Bupivacaine around the saphenous nerve to provide adequate blockade. The goal is to create a circumferential spread of the anaesthetic around the nerve. Anterior femoral cutaneous nerve block- With the patient in the same position and the USG probe in mid-thigh level (same area as adductor canal block), try to locate the nerves in the plane above the sartorius muscle and fascia lata. Intermediate and Medial branches of femoral nerves (2-3 branches) will be located in this plane. Once the nerve are located, the needle is redirected towards the nerve and 2-3 ml of 0.25% bupivacaine will be injected around the nerves (Total of 10ml) to complete the block.
Frequency- once
Route of administration- IM
Total duration - 5-10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 years and older undergoing unilateral TKR
2. ASA classification I-III.
3. Patients capable of providing informed consent or with consent provided by a legal guardian.
4. Patients who can comprehend and cooperate with study procedures and pain assessment tools.
|
|
| ExclusionCriteria |
| Details |
1. Patients with contraindications or allergies to local anaesthetics used in nerve block procedures.
2. Patients scheduled for emergency orthopaedic procedures.
3. Patients with chronic opioid use or opioid tolerance.
4. Patients with pre-existing neurological disorders that may affect pain perception.
5. Patients with coagulopathies or those on anticoagulant therapy that cannot be temporarily stopped.
6. Known allergies to components of the nerve block procedures.
7. Patients with active infections or open wounds at the site of the nerve block.
8. Pregnant or lactating women.
9. Patients currently enrolled in other clinical trials or studies involving pain management techniques.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate Postoperative Pain Relief |
At baseline , 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine functional outcomes: Assess the impact of the AFCNB & ACB on early ambulation & functional recovery in the immediate postoperative period. The Timed Up & Go (TUG) test results at 24 hours postoperatively will be noted in comparison to pre-op TUG test results. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Pain management is a fundamental aspect of patient care after orthopaedic surgery. As surgical techniques continue to advance, so do the methods of perioperative pain control. Among the many strategies for postoperative analgesia, peripheral nerve blocks have gained recognition as effective tools in reducing pain and opioid consumption, and promoting early ambulation after Total Knee Replacement (TKR) surgeries. Adductor canal block (ACB) has shown promise in providing effective pain relief and is motor sparing as it targets the sensory division of the femoral nerve (Saphenous nerve). However, some recent studies have shown that it covers only limited area of the incision site and provide only partial analgesia[1]. Blocking, the Intermediate and Medial cutaneous nerve together known as the Anterior femoral cutaneous nerve, that covers the supply of anterior and medial aspect of thigh and knee has shown to provide excellent analgesia in one of the studies. However, further studies are needed to overcome the limitations and provide additional evidence of the benefit of combining Anterior femoral cutaneous nerve block (AFCNB) with Adductor canal block (ACB).
This study aims to evaluate the analgesic efficacy of the AFCNB combined with the ACB versus adductor canal block (ACB) alone in patients undergoing TKR surgeries. It will shed light on the optimal technique for improved postoperative pain management and patient satisfaction. This study also endeavours to address a significant gap in current knowledge and inform clinical practice, ultimately enhancing the quality of care for patients after total knee replacement.
|