| CTRI Number |
CTRI/2024/08/071958 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| 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
|
COMPARISON OF TWO COMBINED NERVE BLOCKS FOR POSTOPERATIVE PAIN RELIEFE IN TOTAL KNEE REPLACEMENT
|
|
Scientific Title of Study
|
COMBINED ADDUCTOR CANAL BLOCK AND
IPACK BLOCK VERSUS COMBINED FEMORAL NERVE BLOCK
AND SCIATIC NERVE BLOCK FOR POST
OPERATIVE ANALGESIA IN TOTAL KNEE
ARTHROPLASTY :
A PROSPECTIVE RANDOMISED DOUBLE
BLIND COMPARATIVE 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 |
Rimple Shah |
| Designation |
Resident doctor |
| Affiliation |
Government Medical College Baroda |
| Address |
Department of Anesthesiology New Surgical Block SSG Hospital
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
8460680897 |
| Fax |
|
| Email |
rimpleshah04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Lalchandani |
| Designation |
Associate Professor |
| Affiliation |
Government medical college Baroda |
| Address |
Department of Anesthesiology New Surgical Block SSG Hospital
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9274586809 |
| Fax |
|
| Email |
lalchandanikavita@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Rimple shah |
| Designation |
Resident doctor |
| Affiliation |
Government Medical College Baroda |
| Address |
Department of Anesthesiology New Surgical Block SSG Hospital
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
8460680897 |
| Fax |
|
| Email |
rimpleshah04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology , SSG hospital, vadodara-390001, gujarat , india
|
|
|
Primary Sponsor
|
| Name |
Government Medical College Baroda |
| Address |
Department of Anesthesiology New Surgical Block SSG Hospital
Vadodara |
| Type of Sponsor |
Government 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 Rimple Shah |
SSG HOSPITAL VADODARA |
Ortho Operation Theatre, New Surgical Block SSG Hospital vadodara
Vadodara
Vadodara
GUJARAT |
8460680897
rimpleshah04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical and health research, government medical College baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG GUIDED COMBINED ADDUCTOR CANAL BLOCK AND IPACK BLOCK |
1. ADDUCTOR CANAL BLOCK For USG-guided ACB, the probe will be placed at the medial part of the thigh and, the superficial femoral artery will be identified underneath the Sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery. Needle will be inserted in-plane in a lateral-to-medial direction and advanced towards the superficial femoral artery and the saphenous nerve. After negative aspiration, 1–2 mL of the drug mixture of inj Bupivacaine 0.25% will be injected to verify Correct placement of the needle.Then 20 ml of the drug mixture of Bupivacaine(0.25%) will be injected to complete the block. 2.IPACK BLOCK with the patient in supine position, pillow below leg and knee slightly flexion, the IPACK block will be given scanning the popliteal fossa with a curved low-frequency transducer.The area will be scanned proximally to identify the popliteal artery and femoral shaft.Then transducer will slide proximally until the condyle disappeared and the femoral shaft will be identified. At this point, the needle will be inserted in-plane at the lateral aspect of the transducer and needle tip will be located between the femur and popliteal artery. After confirmation of needle placement 20 ml of the drug mixture of Bupivacaine(0.25%) will be injected after negative aspiration. |
| Comparator Agent |
USG GUIDED FEMORAL NERVE BLOCK AND SCIATIC NERVE BLOCK |
1.FEMORAL NERVE BLOCK
With the patient in the supine position, the skin over the femoral crease will be
disinfected and the transducer will be positioned to identify the femoral artery and nerve.The nerve is
enveloped within two layers of the fascia iliaca. The femoral nerve typically is
visualized at a depth of 2–4 cm.Once the femoral nerve is identified,The needle will be inserted inplane in a lateral to medial orientation and advanced toward the femoral nerve.A local anesthetic solution of 15mL of 0.25% bupivacaine will then injected
2.SCIATIC NERVE BLOCK
Patients in the sciatic nerve group(Anterior Approach ) will be placed in supine
position with the hip and knee on the operated side flexed and the leg externally
rotated at approximately 45 degrees. After skin sterilization The ultrasound transducer will first be positioned perpendicular to the skin approximately 8 cm distal to the inguinal crease. The location will then scanned by sliding and tilting the transducer until a clear transverse image of the hyperechoic sciatic nerve located posterior and medial to the lesser trochanter will be obtained .Once the sciatic nerve is identified The needle will be advanced slowly A nerve stimulator with current intensity 2mA with stimulating frequency of 2 Hz will be turned on to elicit foot plantarflexion or dorsiflexion at 0.7 mA. A drug solution of 25mL of 0.25% bupivacaine will then injected. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age group- 40-85 yr
Either sex
ASA –I II III
Patient posted for elective Total knee Arthroplasty.
Patient able to give verbal and informed consent.
Patient able to understand VAS regarding assessment of pain |
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to local anesthetics.
Patient with local site infection
Patient with coagulopathy disorder
Patient with cognitive and psychiatric illness
Patient with peripheral neuropathy and neurological deficit
Patient with severe cardiovascular, respiratory, renal and
hepatic disease (ASA-IV) |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia using VAS score |
till 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of rescue analgesia required in 24 hrs
Degree of active knee flexion at 20 hr and 24 hr post procedural using goniometer
Extent of motor blockage using Modified Bromage scale
Post procedural Hemodynamics
Complications like Nerve injury, Hematoma, local anaesthetic systemic toxicity. |
till 24 hr |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 4 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="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
|
Our goal of study is to compare efficacy of two group of regional blocks For post-operative analgesia in total knee arthroplasty patients. 32 patients will be randomly divided into two groups who are posted for elective total knee arthroplasty. In one group , ultrasound guided adductor canal block and IPACK block will be given postoperatively . In second group ,ultrasound guided femoral nerve block and sciatic nerve block (Anterior approach) will be given postoperatively . Duration of analgesia will be assessed using VAS score till 24hr as a primary outcome . as a secondary outcome Total number of dose of rescue analgesia given in the 24hr post procedural , Degree of active knee flexion at 20hr and 24hr post procedural using goniometer ,vital parameters at timely interval till 24hr , extent of motor blockage post procedural will be assessed
|