| CTRI Number |
CTRI/2024/08/072985 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the effectiveness of ultrasound guided pain relief methods for knee replacement surgeries |
|
Scientific Title of Study
|
To study the analgesic effectiveness of anterior femoral cutaneous nerve block in addition to proximal adductor canal block and local infiltration analgesia in patients undergoing unilateral primary total knee arthroplasty: A randomised 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 |
Debesh Bhoi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5020, 5th floor, Department of Anaesthesiology, Pain medicine and critical care, AIIMS New Delhi, South Delhi.
South
DELHI
110029
India |
| Phone |
7042129428 |
| Fax |
|
| Email |
drdebeshbhoi@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Debesh Bhoi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5020, 5th floor, Department of Anaesthesiology, Pain medicine and critical care, AIIMS New Delhi, South Delhi.
South
DELHI
110029
India |
| Phone |
7042129428 |
| Fax |
|
| Email |
drdebeshbhoi@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sudhir Anand |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5011, Anaesthesiology office, Department of Anaesthesiology, Pain medicine and critical care, 5th floor, Academic block, AIIMS New Delhi, South Delhi
South
DELHI
110029
India |
| Phone |
8825698405 |
| Fax |
|
| Email |
assasudhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain medicine and critical care, AIIMS New Delhi, Ansari nagar 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology, Pain medicine and critical care, AIIMS New Delhi, Ansari nagar, New Delhi 110029 |
| 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 |
| Dr Debesh Bhoi |
All India Institute of Medical Sciences |
Department of Anesthesiology, Pain medicine and Critical care, Room no 5020, Fifth floor , Academic block, All India Institute of Medical Sciences, Ansari nagar, New Delhi 110029
South
DELHI |
7042129428
drdebeshbhoi@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
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 and local infiltration analgesia |
Patients will receive adductor canal block and Local infiltration analgesia: Patient will made supine and operated limb will be little externally rotated. High frequency linear probe (6-13 MHz) probe will be placed medial side of thigh. Proximal part of adductor canal where the femoral artery is just medial to the sartorius muscle , identified with ultrasound. The needle (10 cm echogenic needle) is entered from lateral to medial, piercing the SM, 5 ml deposited around nerve to vastus medialis and then after piercing VAM, 15 mL LA( Ropivacaine 0.25%) will be injected between the femoral artery and the saphenous nerve for both groups. The injection of LA shapes into a hypoechoic sphere with a hyperechoic structure within represented by the saphenous nerve and posteromedial articular branch of nerve to vastus medialis.: After giving adductor canal block , With the probe in same position proximal adductor canal ,the branches of the anterior femoral cutaneous is found on the subcutaneous plane above the fascia lata covering the sartorius muscle. Anteriorly intermediate femoral cutaneous nerve is seen, needle is injected and 5 ml of 0.25% ropivacaine is injected around the nerve . Further on moving medially medial femoral cutaneous nerve is visualized and another 5 ml of 0.25% ropivacaine is injected. If the nerve is not visualized 10 ml LA will be deposited in superficial plane to sartorius muscle .(as per anatomy of the nerve).This procedure will take around five minutes |
| Intervention |
Anterior femoral cutaneous nerve block + Adductor canal block along with local infiltration analgesia |
Patients will receive adductor canal block and Local infiltration analgesia: Patient will made supine and operated limb will be little externally rotated.
High frequency linear probe (6-13 MHz) probe will be placed medial side of thigh.
Proximal part of adductor canal where the femoral artery is just medial to the sartorius muscle , identified with ultrasound.
The needle (10 cm echogenic needle) is entered from lateral to medial, piercing the SM, 5 ml deposited around nerve to vastus medialis and then after piercing VAM, 15 mL LA( Ropivacaine 0.25%) will be injected between the femoral artery and the saphenous nerve for both groups. The injection of LA shapes into a hypoechoic sphere with a hyperechoic structure within represented by the saphenous nerve and posteromedial articular branch of nerve to vastus medialis.: After giving adductor canal block ,
With the probe in same position proximal adductor canal ,the branches of the anterior femoral cutaneous is found on the subcutaneous plane above the fascia lata covering the sartorius muscle.
Anteriorly intermediate femoral cutaneous nerve is seen, needle is injected and 5 ml of 0.25% ropivacaine is injected around the nerve .
Further on moving medially medial femoral cutaneous nerve is visualized and another 5 ml of 0.25% ropivacaine is injected. If the nerve is not visualized 10 ml LA will be deposited in superficial plane to sartorius muscle .(as per anatomy of the nerve)
At the end of surgery, in both the groups surgeons will performs local infiltration analgesia using 50 ml of 0.25% ropivacaine + 30 mg ketorolac + 0.3 mg epinephrine around the medial collateral ligament, anterior capsule, fat pad, medial and lateral meniscus remnants and the posterior capsule with care taken to avoid inadverdent peroneal nerve injection.This whole procedure will take around ten minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA I+II+III
2) 18 TO 70 Years
3) Patients undergoing unilateral primary Total knee arthroplasty |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Varus valgus deformity > 20 degree
3.Flexion deformity > 30 degree
4.BMI > 30 kg/sq.cm
5.Contraindication to neuraxial anaesthesia
6.Allergy to local anaesthetics, NSAIDS, Opioids
7.Chronic opioid use > 3 month duration
8.Previous knee surgery
9.Pregnant females at the time of recruitment
10.Progressive neurological deficit in femoral, obturator or sciatic nerve distribution.
11.Severe cardiac co-morbidities, hepatic or renal dysfunction, coagulopathy
|
|
|
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 |
| Cumulative postoperative analgesic consumption in 36 hours as IV morphine equivalents |
36 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Numeric rating scale of pain (0 minimum-10 worst pain) at various intervals
2.NRS at movement after mobilization at various time intervals
3.Time of first rescue analgesic
4.Quality of Recovery (QoR -15) at 24 hr and 48 hr
5.Timed up and go (TUG) Test scores
6.Patient satisfaction
7.Length of hospital stay
8.Sleep quality (no of times awakening because of Pain)
9.Observe any adverse effect (following LIA, ACB and AFCB -vascular puncture, motor blockade or Local analgesic systemic toxicity). |
1.0, 30 min, 1 hr,2 , 4 ,6 , 8, 12, 24 ,36 and 48 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
Total knee
arthroplasty (TKA) is commonly conducted surgery and about 2.5 lakh people
undergo TKR in India every year. Failure to provide adequate analgesia may
affect physical rehabilitation, which is important to improve joint range of
motion and promote satisfactory results.Various different peripheral nerve blockade
techniques such as sciatic nerve block, obturator nerve block which
anaesthetize the posterior part of knee, femoral nerve block and adductor canal
block taking care of the anteromedial aspect of knee and obturator nerve block
have been described.Femoral nerve block caused motor blockade of
the quadriceps femoris muscle so to overcome this motor sparing adductor canal
block was given.In order to cover the posterior aspect of
knee, infiltration between the popliteal artery and capsule of the knee (IPACK)
was introduced and combination of ACB with IPACK was preferredThe advent of local infiltration anaesthesia
which is given around the knee involving the medial and lateral remnants,
posterior capsule found noninferior to IPACK.So, the standard block preferred for TKR is
ACB+LIA. Though ACB+LIA is
better it cannot cover the anterior or anteromedial skin incision of the TKR
surgery as the dermatomal distribution of this area is supplied by Anterior
cutaneous femoral nerve. So, we hypothesize that, additional Anterior
femoral cutaneous block, along with proximal ACB and LIA, will empower
analgesia and will reduce the opioid consumption and improves postoperative
recovery. |