| CTRI Number |
CTRI/2025/08/093270 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| 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
|
Comparison of ultrasound guided suprainguinal fascia iliaca block and adductor canal block for pain relief after knee replacement surgery |
|
Scientific Title of Study
|
Comparison of Ultrasound guided Suprainguinal Fascia Iliaca Block and
Adductor Canal Block for postoperative analgesia in patients undergoing 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 |
Parasmani Sahu |
| Designation |
Post Graduate MD student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi
South
DELHI
110029
India |
| Phone |
7898466996 |
| Fax |
|
| Email |
paras236mcvm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shipra Aggarwal |
| Designation |
Consultant and Professor and Guide |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi
South
DELHI
110029
India |
| Phone |
9811420866 |
| Fax |
|
| Email |
shipra.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shipra Aggarwal |
| Designation |
Consultant and Professor and Guide |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi
South
DELHI
110029
India |
| Phone |
9811420866 |
| Fax |
|
| Email |
shipra.mamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi |
|
|
Primary Sponsor
|
| Name |
Parasmani Sahu |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Parasmani Sahu |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi
South
DELHI |
7898466996
paras236mcvm@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adductor Canal Block |
Patients who have undergone Total Knee Arthroplasty post Spinal Anaesthesia will be giving Local Infiltration Anesthesia in Knee. Afterwards patient will be giving Adductor Canal Block under Ultrasound guidance. We will be observing pain relief at different time intervals post operatively using Numerical Rating Scale score |
| Intervention |
Suprainguinal Fascia Iliaca Block |
Patients who have undergone Total Knee Arthroplasty post Spinal Anaesthesia will be giving Local Infiltration Anesthesia in Knee. Afterwards patient will be giving Suprainguinal Fascia Iliaca Block under Ultrasound guidance. We will be observing pain relief at different time intervals post operatively using Numerical Rating Scale score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients undergoing elective Total Knee Arthroplasty under Spinal Anaesthesia
2) American Society of Anesthesiologists (ASA) Grade I,II,III |
|
| ExclusionCriteria |
| Details |
1) Contraindications to Suprainguinal Fascia Iliaca Block and Adductor Canal Block
2) Patients receiving opioids for chronic analgesic therapy
3) Contraindications to Subarachnoid block
4) Inability to comprehend Numerical Rating Scale |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of pain relief achieved as assessed by Numerical Rating Scale at rest |
At 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NRS at rest and on movement |
NRS at rest at 0,1,2,4,8 and on movement at 24 hours |
| Time to first rescue analgesia |
After the end of Surgery and Block given |
| Total analgesic requirement post operatively |
Within 24 hours postoperatively |
| Motor power assessment of Quadriceps muscle by 3 point 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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a prospective interventional randomized comparative trial, comparing the Ultrasound guided Suprainguinal Fascia Iliaca Block (30 ml of 0.25% Bupivacaine and 30 mcg Clonidine) and Adductor Canal Block (30 ml of 0.25% Bupivacaine and 30 mcg of 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 Scale (NRS) postoperatively. |