- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06296758
SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries
Femoral Nerve Blockade (FNB) vs Suprainguinal Fascia Iliaca Block (SiFi) for Hip Fracture Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hip fracture in the elderly is an increasingly common problem worldwide. Nearly all patients with a hip fracture undergo surgery. Patients with hip fractures often have significant pain, particularly with movement, and surgical fixation is associated with significant pain.
The treatment of pain with the use of a multimodal analgesic regimen is a major priority for elderly patients with hip fractures. These patients are often frail and have multiple medical comorbidities. Hence the use of non-steroidal anti-inflammatories drugs and systemic opioids may be contraindicated or complicated by adverse effects. Regional anesthesia techniques including femoral nerve blocks (FNB) and fascia iliaca compartment blocks (FICB) are frequently utilized as part of multimodal analgesia due to their relative lack of side-effects. Femoral nerve blockade and suprainguinal fascia iliaca (SiFi) blockade have been described for this indication. Several studies have investigated the analgesic efficacy of the SiFi block after total hip arthroplasty. However, randomized controlled trials on the analgesic efficacy of the SiFi block for pain after hip fracture surgery are not plentiful and subject to methodological concerns.
Objectives:
The primary objective is to test the hypothesis that in patients undergoing hip fracture surgery, suprainguinal fascia iliaca block is associated with improved pain scores and a reduction in opioid utilization when compared with femoral nerve block. Secondary objectives will be to compare time to mobilization, time to readiness for discharge and complications associated with both nerve block techniques.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, t6g2b7
- University of Alberta Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 or greater
- Having hip fracture surgery at the University of Alberta Hospital
- Suitable for multimodal analgesia including a peripheral nerve block
Exclusion Criteria:
- Contraindication to a nerve block technique
- Refuses consent for a nerve block technique
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SIFI local anesthesia
Subjects randomized to the SiFi arm will have an ultrasound-guided suprainguinal fascia iliaca single shot block performed preoperatively in the anesthesia block room with 40ml of 0.2% ropivacaine local anesthetic.
This will be reduced to 30 ml in patients under 60 kg.
|
ultrasound-guided suprainguinal fascia iliaca block with 40ml of ropivacaine local or ultrasound-guided femoral nerve block with 20ml of ropivacaine local anesthetic
|
|
Active Comparator: FNB local anesthesia
Subjects randomized to the FNB arm will have an ultrasound-guided femoral nerve single shot block performed preoperatively in the anesthesia block room with 20ml of 0.5% ropivacaine local anesthetic.
This will be reduced to 15ml in patients under 60 kg.
|
ultrasound-guided suprainguinal fascia iliaca block with 40ml of ropivacaine local or ultrasound-guided femoral nerve block with 20ml of ropivacaine local anesthetic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain
Time Frame: 48 hours
|
Postoperative numerical pain rating scale (NRS) pain scores
|
48 hours
|
|
Postoperative analgesics administered
Time Frame: 48 hours
|
Postoperative opioid utilization
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobilization
Time Frame: 48 hours
|
Time to first mobilization
|
48 hours
|
|
Time to readiness for discharge
Time Frame: 48 hours
|
Time to 'ready for discharge'
|
48 hours
|
|
Complications
Time Frame: 48 hours
|
Complications associated with both block techniques
|
48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SiFi_HIP FRACTURE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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