| CTRI Number |
CTRI/2024/05/066952 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| 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 the effectiveness of two nerve block pain management techniques in patients undergoing hip fracture repair surgery |
|
Scientific Title of Study
|
A Prospective randomized double blind study comparing the effectiveness of ultrasound guided supra inguinal fascia iliaca block versus femoral nerve block for peri operative analgesia in hip fracture arthroplasties conducted under spinal anesthesia |
| 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 Aldrin rappai |
| Designation |
Dnb Anaesthesiology registrar |
| Affiliation |
Primary registrar in Fortis hospital Mulund |
| Address |
Department of Anaesthesia
Division 1
room number 5
Fortis Hospital, Mulund Goregaon Link Road
Mumbai
MAHARASHTRA
400078
India |
| Phone |
9496201024 |
| Fax |
|
| Email |
aldrinrappai007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta shetty |
| Designation |
Senior consultant |
| Affiliation |
Senior consultant Fortis hospital Mumbai |
| Address |
Department of anaesthesia, division 1, room number 5, Fortis Hospital,
Mulund Goregaon
Link Road,
Mumbai
Mumbai
MAHARASHTRA
400078
India |
| Phone |
9819391716 |
| Fax |
|
| Email |
s1v1shetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta shetty |
| Designation |
Senior consultant |
| Affiliation |
Senior consultant Fortis hospital Mumbai |
| Address |
Department of anaesthesia, division 1, room number 5, Fortis Hospital,
Mulund Goregaon
Link Road,
Mumbai
Mumbai
MAHARASHTRA
400078
India |
| Phone |
9819391716 |
| Fax |
|
| Email |
s1v1shetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fortis Hospitals Limited
Mulund Goregaon Link road
Bhandup west, Mumbai
Pin 400078, india
Tel : 91-22-43654365
website: www.fortishealthcare.com |
|
|
Primary Sponsor
|
| Name |
Fortis Hospitals Limited |
| Address |
Mulund goregaon road,
Bhandup west,Mumbai-400078
Maharashtra ,India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sangeeta shetty |
Fortis Hospital |
Anaesthesia department, division 1 , room number 5 ,Mulund Goregaon Link Road Mumbai Maharashtra 400078
Mumbai
MAHARASHTRA |
9819391716
s1v1shetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional academic ethics committee, Fortis hospitals limited |
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 |
Femoral nerve block |
Femoral nerve block using 0.2% ropivacaine 20ml plus 4mg dexamethasone 20 min prior to spinal anaesthesia in the recovery room and look for spinal postioning and peri operative pain scores 24 hr post operation |
| Comparator Agent |
Supra inguinal fascia iliaca compartment block |
Supra inguinal fascia iliaca compartment block using 0.2% ropivacaine 20ml plus 4mg dexamethasone 20 min prior to spinal anaesthesia in the recovery room and look for spinal postioning and peri operative pain scores 24 hr post operation |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Informed Written consent
2) Elective hip fracture arthroplasty procedures under spinal anaesthesia.
3) American Society of anaethesiologist physical statue grade I,II,III.
4) Age 40 to 90 years of either gender |
|
| ExclusionCriteria |
| Details |
1) Contraindication for spinal anaesthesia (Central or peripheral neurological deficits, bleeding tendency, previous spine instrumentation , major spine deformity)
2) Polytrauma
3) Infection at the block site
4) Allergy to Ropivacaine |
|
|
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 |
Visual analogue scale at rest
Visual analogue scale at movement |
T0 pre block
TA arrival at Operation theatre
TP arrival at post anaesthesia care unit
2hr post operation
6hr post operation
12hr post op
18hr post op
24hr post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean arterial pressure
Heart rate
Oxygen saturation
Motor block grade
Numbness
Nausea/Vomiting
Time taken to perform block
Time taken to perform spinal anaesthesia
Total amount of tramadol consumed in 24 hr
Ease of positioning for spinal anaesthesia
Time to ambulation
Patient satisfaction score
Rescue analgesia |
T0 pre block
TA arrival at Operation theatre
TP arrival at post anaesthesia care unit
2hr post operation
6hr post operation
12hr post op
18hr post op
24hr post op |
|
|
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 3 |
|
Date of First Enrollment (India)
|
17/05/2024 |
| 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="1"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 meta analysis by Anger et al fascia iliaca block is recommended as the preferred nerve block when a nerve block is indicated for total hip fracture arthroplasites However, Li et al in their meta analysis recommended that more high quality RCTs are necessary for proper comparison of the efficacy and safety of femoral nerve block and fascia iliaca block Usg guided supra inguinal fascia iliaca block is more consistent in blocking the lateral femoral cutaneous nerve than femoral nerve block; however no difference was seen in terms of pain scores , opioid consumption, and side effects. Hence we wanted to study whether there is any benefit in changing the common practice of using the femoral nerve block to using the supra inguinal fascial block in the peri operative management of patients with hip fractures presenting for hip arthroplasties under spinal anaesthesia |