| CTRI Number |
CTRI/2025/08/092600 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Two Types of Nerve Blocks for Pain Relief After Knee Replacement Surgery |
|
Scientific Title of Study
|
Comparison of ultrasound guided femoral triangle block and adductor canal block for postoperative analgesia in total knee arthroplasty |
| 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 Lohith H T |
| Designation |
PG resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari Nagar east, New Delhi,
New Delhi
DELHI
110029
India |
| Phone |
8296821433 |
| Fax |
|
| Email |
lohithht52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shipra Aggarwal |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari Nagar east, New Delhi,
New Delhi
DELHI
110029
India |
| Phone |
9818133349 |
| Fax |
|
| Email |
Shipra.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shipra Aggarwal |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari Nagar east, New Delhi,
New Delhi
DELHI
110029
India |
| Phone |
9818133349 |
| Fax |
|
| Email |
Shipra.mamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital, ansari nagar, south delhi, Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Ansari Nagar east, New Delhi, Delhi, 110029 |
| 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 Lohith H T |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of anaesthesia and intensive care, 3rd floor, sports injury centre, Ansari Nagar east, New Delhi,
New Delhi
DELHI |
8296821433
lohithht52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir medical college and Safdarjung hospital institutional ethics committee |
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 |
Ultrasound guided adductor canal block |
Ultrasound guided adductor canal Block will be given with 15ml 0.25% bupivacaine and 30 mcg clonidine postoperatively.
Assesment of pain using NRS done postoperatively. |
| Comparator Agent |
Ultrasound guided femoral triangle block |
Group F: Ultrasound guided Femoral Triangle Block will be given with 15ml 0.25% bupivacaine and 30 mcg clonidine postoperatively. Assesment of pain using NRS done postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-65 years with American Society of Anesthesiologists physical status I-III scheduled for elective unilateral Total Knee Arthroplasty |
|
| ExclusionCriteria |
| Details |
1. Contraindications to Femoral Triangle and Adductor Canal Block.
2. Patients receiving opioids for chronic analgesic therapy.
3. Contraindication to Subarachnoid Block.
4. Inability to comprehend Numeric Rating Scale. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of ultrasound guided Femoral triangle block and adductor canal block for pain relief using the numerical rating score(NRS) at rest in patients undergoing total knee arthroplasty |
At 2 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NRS at rest |
At 0, 1, 4, 8 and 24 hours |
| NRS on movement |
At 24 hours |
| Time to first rescue analgesia |
|
| Total analgesic consumption postoperatively |
In first 24 hours |
| Quadriceps muscle strength using Bromage scale |
At 24 hours postoperatively |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is a prospective interventional randomized comparative trial, Comparing the ultrasound guided Femoral triangle block ( 15 ml of 0.25 % bupivacaine and 30 mcg clonidine) and adductor canal block ( 15 ml of 0.25% bupivacaine and 30 mcg clonidine) in patients undergoing total knee arthroplasty under subarachnoid block in a single centre in India. The primary outcome will be measured using Numerical rating score (NRS) postoperatively. |