| CTRI Number |
CTRI/2025/04/084934 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| 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
|
Study Of Combined Genicular nerve block and Adductor canal block VS IPACK and Adductor canal block for Post Operative Pain relief in Patients Operated for knee replacement surgery |
|
Scientific Title of Study
|
Comparison Of Post-Operative Analgesia Between Ultrasound Guided Combined Genicular Nerve Block And Adductor Canal Block VS Combined IPACK And Adductor canal block for Total Knee Replacement Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshkumar Adroja |
| Designation |
Resident Doctor |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department of Anaesthesiology
New Surgical Block
SSG hospital
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
7600014012 |
| Fax |
|
| Email |
harsh.adroja1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Patel |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department of Anaesthesiology
New Surgical Block
SSG hospital
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
|
| Email |
mgpatel111@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Patel |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department of Anaesthesiology
New Surgical Block
SSG hospital
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
|
| Email |
mgpatel111@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
2nd Floor
New Surgical Block, SSG Hospital, Anandpura, Vadodara,Gujarat,India
PINCODE-390001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College Vadodara |
| Address |
Department of Anaesthesiology
2nd Floor
New Surgical Block, SSG Hospital, Anandpura, Vadodara,Gujarat,India
PINCODE-390001 |
| 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 Harshkumar Adroja |
SSG Hospital |
Trauma Operation Theatre
Department of Orthopaedics
1st floor
New Surgical Block
SSG hospital
Vadodara,Gujarat,India
PINCODE- 390001
Vadodara
GUJARAT |
7600014012
harsh.adroja1998@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ULTRASOUND GUIDED COMBINED GENICULAR NERVE BLOCK AND ADDUCTOR CANAL BLOCK |
Total drug prepared 40cc.
38 cc Inj Bupivacaine(0.25%)+ inj Dexamethasone 2 cc
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 correct placement of needle and negative aspiration, 20 ml of the drug mixture will be injected.
2. GENICULAR NERVE BLOCK :-
For the genicular blocks, the ultrasound transducer will be placed parallel to the shaft of femur & tibia and the epicondyle will identified. The superolateral, superomedial, and inferomedial genicular arteries, which follow a similar route with their each genicular nerve will be visualized close to the periosteal areas. A 20G needle with a tip length of 50 mm will directed in the plane of the ultrasound probe in the long-axis view. After confirming the placement of the needle-tip next to a genicular artery, the superior lateral, superior medial, and inferior medial genicular nerves will be given a total amount of 20 mL of drug mixture will be devided in equal increments at supralateral, supramedial, inframedial sites.
|
| Comparator Agent |
USG GUIDED COMBINED IPACK AND ADDUCTOR CANAL BLOCK |
Total drug prepared 40cc.
38 cc Inj Bupivacaine(0.25%)+ inj Dexamethasone 2 cc
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 correct placement of needle and
negative aspiration, 20 ml of the drug mixture will be
injected.
2. IPACK BLOCK;-
The curvalinior transducer of the ultrasound will be used for the visualization of the anatomic landmarks. The procedure for the IPACK blocks will be initiated by the visualization of the popliteal artery and posterior surface of the distal femur. Then, the image of the femoral condyles and the popliteal artery will obtained. A 20G ultrasound-visible echogenic stimulation needle with a tip length of 100 mm for peripheral nerve blocks will be inserted in a medial to the lateral plane, parallel to the femur in the middle area between the popliteal artery and the femur. 20 mL of drug mixture will be given. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 25 to 85 years
Either sex
ASA Grading I II III
Patient posted for total knee Replacement.
Patient able to understand VAS regarding assessment of pain.
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to local anesthetic agents.
Patient with local site infection.
Patient with coagulopathy disorder
Patient with uncontrolled medical conditions like hypertension, diabetes mellitus, renal failure., etc
Patient with cardiac, renal, respiratory, neurological conditions |
|
|
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 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total number of rescue analgesia required in 24 hours after surgery
Changes in hemodynamic parameters
Post-operative complications
|
till 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
01/05/2025 |
| 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 pain relief in total knee replacement patients. 64 patients will be randomly divided into two groups who are posted for elective total knee replacement surgery. In one group , ultrasound guided adductor canal block and Genicular nerve block will be given postoperatively . In second group ,ultrasound guided adductor canal block and IPACK block will be given postoperatively . Duration of analgesia will be assessed using VAS score till 24 hrs as a primary outcome . as a secondary outcome Total numeber of rescue analgesia in 24 hrs , hemodynamic parameters, postoperative complication will be assessed |