| CTRI Number |
CTRI/2024/04/065146 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Femoral nerve block versus fascia iliaca block in reducing pain of fracture of femur |
|
Scientific Title of Study
|
A comparative study of analgesic efficacy of ultrasound guided femoral nerve block versus fascia illiaca compartment block using 0.5% ropivacaine in patient with fracture femur in reducing pain associated with mobilisation and positioning for subarachnoid block |
| 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 TEJPAL YADAV |
| Designation |
Resident doctor |
| Affiliation |
Room no. 111,Department of emergency medicine ,JLN medical college ajmer |
| Address |
Room No. 111 ,Resident hostel
JLN Medical college ajmer
PIN 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
8432423872 |
| Fax |
|
| Email |
tejpalyadavmbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sharad jain |
| Designation |
Associate professor |
| Affiliation |
J.L.N. medical college ajmer ,rajasthan |
| Address |
Saraswati villa , balaji nagar, ajmer,rajasthan,PIN 305004
Ajmer
RAJASTHAN
305004
India |
| Phone |
9829680727 |
| Fax |
|
| Email |
nikky7mbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TEJPAL YADAV |
| Designation |
Resident doctor |
| Affiliation |
J.L.N. Medical college AJMER Rajasthan |
| Address |
Room No. 111 ,Department of emergency medicine ,JLN medical college ajmer rajasthan
PIN 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
8432423872 |
| Fax |
|
| Email |
tejpalyadavmbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of emergency medicine ,Room no. 111,
J.L.N. Medical college ajmer PIN-305001,rajasthan india |
|
|
Primary Sponsor
|
| Name |
Department of emergency medicine JLN Medical college Ajmer |
| Address |
J.L.N. medical college ajmer rajasthan india 305001 |
| 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 Tejpal Yadav |
JLN Hospital Ajmer |
Casualty OPD of Emergency medicine department
Ajmer
RAJASTHAN |
8432423872
tejpalyadavmbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe JLN medical college ajmer rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femoral nerve block and fascia illiaca block |
Ultrasound guided femoral nerve block and fascia illiaca compartment block by using 0.5% ropivacaine in fracture femur patient for 1 year duration from date of first intervention |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patient with fracture shaft of femur with pain and no any othe neurological deficit or head injury |
|
| ExclusionCriteria |
| Details |
Patient not willing for study
Patient less than 18 years of age and more than 70 years
Patient has preexisting liver pathology which includes acute/chronic hepatitis before ingestion.
Patient has preexisting renal pathology which includes acute chronic renal failure before ingestion.
History of psychiatric illness
History of respiratory or cardiac diseases
History of epilepsy or bleeding tendencies
Treatment initiated before arriving to the emergency OPD |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study of analgesic efficacy of femoral nerve block vs fascia iliaca block in fracture shaft of femur pain |
0 hrs
30 min.
1 hrs
3 hrs
6 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study of reducing pain from block through visual analog score |
0 hrs
30 min.
1 hrs
3 hrs
6 hrs
9 hrs |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/04/2024 |
| 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
|
In this study ,we will compare of analgesic efficacy of ultrasound guided femoral nerve block versus fascia iliaca block using 0.5% ropivacaine in patient with fracture femur in reducing pain associated with mobilisation and positioning of subarachanoid block |