| CTRI Number |
CTRI/2025/12/098608 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Studying whether adding dexmedetomidine to ropivacaine in a nerve block (suprainguinal fascia iliaca block) improves pain control after femur fracture surgery. |
|
Scientific Title of Study
|
Assessment of the effect of DEXMEDETOMIDINE as an adjuvant for ROPIVACAINE in suprainguinal facia iliaca compartment block for femur fixation surgeries. |
| 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 Mrinal Kaushik |
| Designation |
Junior resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra Institute of Higher Education and Research,
Chennai,
Tamil Nadu
600116
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9445410624 |
| Fax |
|
| Email |
mrinalkaushik1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Vakamudi |
| Designation |
Professor , Head of department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department Of Anaesthesiology,Sri Ramachandra Institute Of Higher Education And Research
Chennai
TAMIL NADU
600116
India
Chennai
TAMIL NADU
60016
India |
| Phone |
9840022626 |
| Fax |
|
| Email |
vakamudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Vakamudi |
| Designation |
Professor , Head of department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department Of Anaesthesiology,Sri Ramachandra Institute Of Higher Education And Research
Chennai
TAMIL NADU
600116
India
TAMIL NADU
60016
India |
| Phone |
9840022626 |
| Fax |
|
| Email |
vakamudi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur , Chennai - 60116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Chennai,
Tamil Nadu ,
600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mrinal Kaushik |
Sri Ramachandra Institute of Higher Education and Research |
OR Complex,Department Of
Anaesthesiology,
SriRamachandra Institute Of
Higher Education And Research,
Chennai,
TAMIL NADU
Chennai
TAMIL NADU |
9445410624
mrinalkaushik1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH 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 |
| Intervention |
Ultrasound guided suprainguinal facia iliaca compartment block. |
The supra inguinal facia iliaca compartment block is a safe and simple block performed under ultrasound guidance where the needle tip is positioned between the internal oblique and iliacus muscle and the facia iliaca and the local anaesthetic with adjuvant ( ROPIVACAINE + DEXMEDETOMIDINE) is injected.
Duration of intervention - 10 minutes. |
| Comparator Agent |
Ultrasound guided suprainguinal facia iliaca compartment block. |
The suprainguinal facia iliaca compartment block is a safe and simple block performed under ultrasound guidance where the needle tip is positioned between the internal oblique and iliacus muscle and facia iliaca and the local anaesthetic ( plain ROPIVACAINE) is injected.
Duration of intervention - 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA)Status – 1 to 3
Patients posted for femur fixation surgery.
|
|
| ExclusionCriteria |
| Details |
1. Refusal to participate.
2. BMI more than 45Kg/m2.
3. History of heart failure/ renal failure/ liver failure.
4. Contraindication for spinal anaesthesia.
5. Allergy to local anaesthetics.
6. Prior surgery in the inguinal or suprainguinal area.
7. Pregnancy.
8. On chronic opioid therapy.
9. Prior history of myocardial infarction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the time to first rescue analgesia. |
0 hours to 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. VAS scores on arrival to PACU and every 4 hours for 24 hours.
2. Presence or absence of quadriceps weakness during mobilisation.
3. Ability to participate in mobilisation.
4.Total anaelgesic consumption in 24 hours. |
15 minutes, 30 minutes,
1,2,4,8,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
18/12/2025 |
| 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 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
|
Effective perioperative pain management is the cornerstone of a successful orthopaedic surgery, particularly in femur fixation surgeries, which are associated with significant postoperative pain. Regional anaesthetic techniques such as the suprainguinal facia iliaca compartment block(FICB) have gained popularity due to their ability to provide targeted anaelgesia while mimimising systemic side effects. Among local anaesthetics, ROPIVACAINE is widely used for its favourable safety profile and prolonged duration of action. However the need for improving the anaelgesic efficacy and duration has led to the use of adjuvants. DEXMEDETOMIDINE, a selective alpha 2 adrenergic agonist has emerged as a promising adjuvant in regional anaesthesia due to its sedative, anaelgesic and opioid sparing properties. The suprainguinal approach to the FICB is a better alternative than the infrainguinal approach with ultrasound guidance reducing the risk of complications. |