| CTRI Number |
CTRI/2025/08/092184 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparison of Genicular Nerve Block and Adductor Canal Block for Pain Relief After Knee Arthroscopy Surgery |
|
Scientific Title of Study
|
Comparative study on Genicular nerve block with Adductor canal block for post operative analgesia in patients undergoing knee arthroscopy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Senthil |
| Designation |
Professor-Anaesthesia |
| Affiliation |
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Salem |
| Address |
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanu |
| Designation |
Assistant professor-Anaesthesia |
| Affiliation |
Vinayaka Missions Kirubanandha Variyar Medical College and Hospitals,Salem |
| Address |
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8056603011 |
| Fax |
|
| Email |
shanushanmugasundharam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V K Shobana |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirubanandha Variyar Medical College and Hospitals,Salem |
| Address |
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
636308 |
| Fax |
|
| Email |
dr.shobana14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirubanandha Variyar Medical College & Hospitals,Salem |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirubanandha Variyar Medical College and Hospitals, |
| Address |
Chinnaseeragapadi,Salem |
| Type of Sponsor |
Private 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 V K Shobana |
Vinayaka Missions Kirubanandha Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU |
9597957880
dr.shobana14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison between Genicular Nerve Block and Adductor Canal Block |
Comparison between Genicular Nerve Block and Adductor Canal Block for Knee Arthroscopy for Post Operative Analgesia using 0.125 % Levobupivacaine and Dexmedetomidine |
| Comparator Agent |
Levobupivacaine and Dexmedetomidine |
Adductor Canal Block in Knee Arthroscopy for Post Operative Analgesia using 0.125 % Levobupivacaine and Dexmedetomidine |
| Comparator Agent |
Levobupivacaine with Dexmedetomidine |
Genicular Nerve Block in Knee Arthroscopy for Post Operative Analgesia using 0.125% Levobupivacaine with Dexmedetomidine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for elective knee arthroscopic surgeries
2.Patients aged 18-60 years
3.Able to provide informed consent
4.ASA physical status I,II
5.No contraindications to local anaesthetics or coagulopathy |
|
| ExclusionCriteria |
| Details |
1.Patients with contraindications to nerve blocks (coagulopathy or bleeding disorders)
2.Patient refusal
3.ASA physical status III,IV
4.Patients with known allergies to local anaesthetics
5.Patients with neurological deficits,cardiac,renal,hepatic and respiratory insufficiency |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness between genicular nerve block and adductor canal block |
From 0 mins of administering block till patient starts perceiving pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness on Genicular nerve block with Adductor canal block for post operative analgesia in patients undergoing knee arthroscopy |
From 0 point of administering block till the patient receives post operative rescue analgesia |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
10/06/2026 |
| 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
|
This is a Randomised controlled trial comparing the effectiveness of Genicular nerve block and Adductor canal block for post operative analgesia in patients undergoing knee arthroscopic surgeries by estimating the time interval between the first rescue analgesia between the two blocks post operatively. |