| CTRI Number |
CTRI/2022/11/047700 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
25/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of femoral nerve block for pain relief in hip fracture before anaesthesia |
|
Scientific Title of Study
|
Effectiveness of femoral nerve block for pain relief in hip fracture before anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Toral Ganesh Rajput |
| Designation |
M.D anaesthesiology resident |
| Affiliation |
BJMC ahmedabad |
| Address |
F3 Department of anaesthesia,ahmedabad,gujarat
380016
India
Old PG Hostel, BJ Medical College, Asarwa
Ahmadabad
GUJARAT
380016
India |
| Phone |
7600056220 |
| Fax |
|
| Email |
toralrajput23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drmrunalini patel |
| Designation |
assistant Professor |
| Affiliation |
BJMC ahmedabad |
| Address |
F3 Department of anaesthesia,ahmedabad,gujarat
380016
India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9879552340 |
| Fax |
|
| Email |
dr.mrunalinipatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Toral ganesh rajput |
| Designation |
M.D anaesthesiology resident |
| Affiliation |
BJMC ahemedabad |
| Address |
F3 Department of anaesthesia,ahmedabad,gujarat
380016
India
Old PG Hostel, BJ Medical College, Asarwa
Ahmadabad
GUJARAT
380016
India |
| Phone |
7600056220 |
| Fax |
|
| Email |
toralrajput23@gmail.com |
|
|
Source of Monetary or Material Support
|
| F3 department of anaesthesiology,BJMC,civil hospital,ahmedabad |
|
|
Primary Sponsor
|
| Name |
Government supply |
| Address |
F3 Department of anaesthesia,ahmedabad,gujarat
380016
India |
| 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 |
| Toral ganesh rajput |
Civil hospital,BJMC,ahmedabad |
F3 Department of anaesthesia,ahmedabad,gujarat
380016
India
Ahmadabad
GUJARAT |
07600056220
toralrajput23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTION OF ETHICS COMMITTEE B.J MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femoral nerve block |
femoral nerve block will be given with injection bupivacaine 0.25% 20ml using landmark technique or usg guided.duration :1hour |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I, II, III undergoing elective surgery under spinal anaesthesia.
unilateral hip fracture surgery under spinal anaesthesia
willingness of patient
|
|
| ExclusionCriteria |
| Details |
• Age <18year and >60 years
• Patients having any drug allergy.
• Local site infection
• Patients having Neuromuscular disorder and neurological symptoms
• Patients having coagulation disorder
• Pregnancy
• Patients having b/l hip fracture
• Patient taken any analgesic 8 hours before procedure
• Patient giving negative consent for procedure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain before giving anaesthesia,successful postioning for spinal anaesthesia |
Within 1hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of first analgesic after completion of surgery |
within 24hour |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/11/2022 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Femoral nerve block is effective in pain relief for hip fracture before giving anaesthesia. |