| CTRI Number |
CTRI/2023/06/053456 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
28/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain Relief For Patients With Thigh Bone Fracture Before Positioning Them For Anaesthesia: A Comparison Between Two Different Types Of Nerve Blocks |
|
Scientific Title of Study
|
Analgesia For Positioning For Spinal Anaesthesia In Patients With Femur Fracture: A Comparison Between Femoral Nerve Block And Fascia Iliaca Block -
A Randomised Control Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bellary Prerana Pandurang |
| Designation |
Post graduate |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Dr Prerana Bellary, Post Graduate, Department of Anesthesiology, Karnataka Institute of Medical Sciences, Vidyanagar Hubli
Dharwad
Dharwad
KARNATAKA
580032
India |
| Phone |
9164935294 |
| Fax |
|
| Email |
prerana.bellary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Bhosale |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Dr Raghavendra Bhosale, Associate Professor, Department of Anesthesiology, Karnataka Institute of Medical Sciences, Vidyanagar Hubli
Dharwad
Dharwad
KARNATAKA
580032
India |
| Phone |
9342943765 |
| Fax |
|
| Email |
raghavbhosale3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendra Bhosale |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Dr Raghavendra Bhosale, Associate Professor, Department of Anesthesiology, Karnataka Institute of Medical Sciences, Vidyanagar Hubli
Dharwad
KARNATAKA
580032
India |
| Phone |
9342943765 |
| Fax |
|
| Email |
raghavbhosale3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences, Vidyanagar, Hubli |
|
|
Primary Sponsor
|
| Name |
Dr Bellary Prerana Pandurang |
| Address |
Dr Prerana Bellary, Post Graduate, Department of Anesthesiology, Karnataka Institute of Medical Sciences, Vidyanagar Hubli
Dharwad |
| Type of Sponsor |
Other [SELF] |
|
|
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 Bellary Prerana Pandurang |
Karnataka Institute of Medical Sciences |
Department of Anesthesiology, Karnataka Institute of Medical Sciences, Vidyanagar Hubli
Dharwad
Dharwad
KARNATAKA |
09164935294
prerana.bellary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, KIMS Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascia Iliaca Block |
Patients will receive Fascia Iliaca Block with 30 mL of 0.25% bupivacaine. |
| Comparator Agent |
Femoral Nerve Block |
Patients will receive Femoral Nerve Block with 30 mL of 0.25% bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients belonging to American Society Of Anaesthesiologists(ASA) physical status class 1, 2 and 3
2)Patients giving informed written and valid consent
3)Patients undergoing elective and emergency femur surgeries under central neuraxial blockade |
|
| ExclusionCriteria |
| Details |
1)Patients with infection at the site of administration of block.
2)Patients with known contraindications to spinal anaesthesia
3)Patients having hypersensitivity to any of the study drugs
4)Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of analgesia achieved with the FIB versus FNB for positioning for spinal anesthesia using the numerical rating scale (NRS) |
Comparison of analgesia achieved with the FIB versus FNB for positioning for spinal anesthesia using the numerical rating scale (NRS) at 0,1,2,3,4,5,10,15 minutes after administering the block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of rescue analgesia |
If used in first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
01/07/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- The fractures of the femur, including the fracture of the neck of femur, intertrochanteric, subtrochanteric and shaft of femur fractures, are common orthopedic emergencies. These fractures are extremely painful thus making it difficult for patients to sit for regional anaesthesia.
- Femoral nerve block (FNB) is effective in providing analgesia for femur fractures. It is most commonly employed and considered the standard of care to provide pain relief before positioning a patient for spinal anesthesia. A fascia iliaca compartment block (FICB) is a modification of the femoral nerve block, performed by application of local anaesthetic beneath the fascia iliaca. It provides a block of femoral nerve and lateral femoral cutaneous nerve and rarely of obturator nerve.
- Although both the blocks have been studied individually, there are only a handful of studies comparing both techniques under ultrasound guidance, for making patient positioning for regional anesthesia easy.
|