| CTRI Number |
CTRI/2024/03/064484 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To Compare Two Different Methods using Ultrasound For Preoperative Pain Relief In Hip Surgeries Before Positioning For Spinal Anaesthesia |
|
Scientific Title of Study
|
A Randomized Trial Of Ultrasound Guided Fascia Iliaca Compartment Block(FICB) Vs Femoral Nerve Block(FNB) For Hip Surgeries Before Positioning For Spinal Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIVYA PUSKUR |
| Designation |
Assistant Professor |
| Affiliation |
Bhaskar Medical College |
| Address |
Department of Anaesthesiology,
2nd Floor,
Bhaskar General Hospital,
Survey No. 156 To 162, Amdapur X Road, Yenkapally, Moinabad
Hyderabad
TELANGANA
500075
India |
| Phone |
8886568368 |
| Fax |
|
| Email |
divyapuskur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DIVYA PUSKUR |
| Designation |
Assistant Professor |
| Affiliation |
Bhaskar Medical College |
| Address |
Department of Anaesthesiology,
2nd Floor,
Bhaskar General Hospital,
Survey No. 156 To 162, Amdapur X Road, Yenkapally, Moinabad
TELANGANA
500075
India |
| Phone |
8886568368 |
| Fax |
|
| Email |
divyapuskur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DIVYA PUSKUR |
| Designation |
Assistant Professor |
| Affiliation |
Bhaskar Medical College |
| Address |
Department of Anaesthesiology,
2nd Floor,
Bhaskar General Hospital,
Survey No. 156 To 162, Amdapur X Road, Yenkapally, Moinabad
TELANGANA
500075
India |
| Phone |
8886568368 |
| Fax |
|
| Email |
divyapuskur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaskar Medical College and General Hospital
Survey No. 156 To 162, Amdapur X Road, Yenkapally, Moinabad, Ranga Reddy, Hyderabad, Telangana 500075 |
|
|
Primary Sponsor
|
| Name |
Bhaskar Medical College and General Hospital |
| Address |
Survey No. 156 To 162, Amdapur X Road, Yenkapally, Moinabad, Ranga Reddy, Hyderabad, Telangana 500075 |
| Type of Sponsor |
Private 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 Sherry Mathews |
Bhaskar Medical College and General Hospital |
Survey No. 156 To 162, Amdapur X Road, Yenkapally, Moinabad, Ranga Reddy, Hyderabad, Telangana 500075
Hyderabad
TELANGANA |
9848190763
mathewssherry56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaskar Medical College |
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 FASCIA ILIACA COMPARTMENT BLOCK |
40 mL of 0.5% Ropivacaine is given in this group.
The block is given by an expert in regional anaesthesia under ultrasound guidance.
The primary outcome and secondary outcome variables are monitored for 10 minutes
|
| Comparator Agent |
ULTRASOUND GUIDED FEMORAL NERVE BLOCK |
15ml of 0.5% Ropivacaine is given in this group. The block is given by an expert in regional anaesthesia under ultrasound guidance. The primary outcome and secondary outcome variables are monitored for 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA Class 1, 2 & 3 undergoing surgeries for hip fractures |
|
| ExclusionCriteria |
| Details |
Patient refusal
Previous adverse reactions to the local anaesthetics
Patients on anticoagulant & antiplatelet drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS Score |
0, 3, 5, 8 and 10 mins after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the quality of positioning during spinal anaesthesia
Time to perform spinal anaesthesia
Patient satisfaction
|
At the time of performing spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
BACKGROUND: Severe pain associated with hip fractures makes positioning for regional anaesthesia a challenge. Systemic administration of analgesics can have adverse effects. Individually, both the fascia iliaca block (FICB) and femoral nerve block (FNB) have been studied. However, there is little evidence comparing the two. The role of this study is to compare the overall efficacy of the two blocks in patients in patients with hip surgeries before positioning for spinal anaesthesia.
AIM: Primary aim : To assess the overall efficacy for pain relief during patient positioning for spinal anaesthesia
Secondary aim : To assess the quality of positioning during spinal anaesthesia Time to perform spinal anaesthesia Patient satisfaction
METHODOLOGY Inclusion criteria: Patients of ASA class 1,2 & 3 undergoing surgeries for hip fractures
Exclusion criteria: Patient refusal Previous adverse reactions to local anaesthesia Patients on anticoagulant & antiplatelet drugs
Groups: FNB Group: 15ml of 0.5% Ropivacaine FICB Group: 40 ml of 0.5% Ropivacaine
Sample size: 40 patients, 20 in each group
Place of study and duration of study: Bhaskar Medical College and General Hospital 20th March 2024 to 20th September 2024
RESULTS: To be tabulated using appropriate software and published. |