CTRI Number |
CTRI/2023/05/052732 [Registered on: 17/05/2023] Trial Registered Prospectively |
Last Modified On: |
16/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of two blocks in patients going for Spinal anaesthesia for analgesia and positioning for Spinal anaesthesia. |
Scientific Title of Study
|
comparison of USG guided pericapsular nerve group block and fascia iliaca compartment block for positioning and analgesia prior to spinal anaesthesia in hip fracture surgeries |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Susheela Taxak |
Designation |
Senior professor |
Affiliation |
Pt.B.D.Sharma,PGIMS, Rohtak |
Address |
Department of Anaesthesiology, Modular OT 2nd floor, Room no.206,Pt.B.D.Sharma,PGIMS,
Rohtak 1561/J, Medical campus. Rohtak, Haryana Rohtak HARYANA 124001 India |
Phone |
|
Fax |
|
Email |
susheelataxak@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Susheela Taxak |
Designation |
Senior professor |
Affiliation |
PGIMS ROHTAK |
Address |
Department of Anaesthesiology, Modular OT 2nd floor, Room no.206,Pt.B.D.Sharma,PGIMS,
Rohtak 1561/J, Medical campus. Rohtak, Haryana Rohtak HARYANA 124001 India |
Phone |
|
Fax |
|
Email |
susheelataxak@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Upasana |
Designation |
Junior resident |
Affiliation |
PGIMS ROHTAK |
Address |
A 901, A block, Suncity Heights, lahdout road, Rohtak
Rohtak HARYANA 124001 India |
Phone |
7015149969 |
Fax |
|
Email |
upasna.seth.us@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology, Modular OT 2nd floor, Room no.206,Pt.B.D.Sharma,PGIMS,
Rohtak |
|
Primary Sponsor
|
Name |
PGIMS ROHTAK |
Address |
Department of Anaesthesiology, Modular OT 2nd floor, Room no.206,Pt.B.D.Sharma,PGIMS,
Rohtak |
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 |
Susheela Taxak |
PGIMS Rohtak |
Department of Anaesthesiology, Modular OT, 2nd floor,Pt.B.D.Sharma,PGIMS,
Rohtak
Rohtak HARYANA |
9896067416
susheelataxak@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Biomedical research ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
comparison of USG guided pericapsular nerve group block and fascia iliaca compartment block for positioning and analgesia prior to spinal anaesthesia in hip fracture surgeries |
VAS score will be recorded and
Quality of positioning for spinal anaesthesia |
|
Inclusion Criteria
|
Age From |
18.00 Day(s) |
Age To |
65.00 Day(s) |
Gender |
Both |
Details |
ASA 1-3 scheduled for hip surgeries
|
|
ExclusionCriteria |
Details |
Any bleeding tendency and on anticoagulant therapy
• Peripheral neuropathy, allergy to amide local anaesthetics
• Mental disorders, local infection at injection site
• Patients who can sit comfortably or received analgesia 8 hrs prior to surgery
• Patients who refuse to participate in study will be excluded |
|
Method of Generating Random Sequence
|
Stratified randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
VAS score will be recorded
Quality of positioning for spinal anaesthesia |
Vas score
Before block
5min after block
10min after block
20min after block
30min after block |
|
Secondary Outcome
|
Outcome |
TimePoints |
post operative analgesia (VAS Score) |
1 hour
4 hour
8 hour |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
25/05/2023 |
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
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
It is the “Comparison of USG guided pericapsular nerve group block and fascia iliaca
compartment block for positioning and analgesia prior to spinal anaesthesia in hip fracture surgeries. Patients will be assessed based on VAS score and positioning during spinal anaesthesia. |