SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries

NCT ID: NCT06296758

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-05-01

Brief Summary

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The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study.

Detailed Description

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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.

Conditions

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Hip Fractures Surgery Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A concealed-allocation parallel-group blinded randomized controlled clinical
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Randomization will be conducted through blocked randomization with blocks of 4 according to a schedule not known to the investigators using a computerized algorithm. The attending surgeon, anesthetist, and nursing team will be blinded to the randomization assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Regional anesthesia

Intervention Type PROCEDURE

ultrasound-guided suprainguinal fascia iliaca block with 40ml of ropivacaine local or ultrasound-guided femoral nerve block with 20ml of ropivacaine local anesthetic

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.

Group Type ACTIVE_COMPARATOR

Regional anesthesia

Intervention Type PROCEDURE

ultrasound-guided suprainguinal fascia iliaca block with 40ml of ropivacaine local or ultrasound-guided femoral nerve block with 20ml of ropivacaine local anesthetic

Interventions

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Regional anesthesia

ultrasound-guided suprainguinal fascia iliaca block with 40ml of ropivacaine local or ultrasound-guided femoral nerve block with 20ml of ropivacaine local anesthetic

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Derek Dillane

Role: primary

(780) 407-8861

Other Identifiers

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SiFi_HIP FRACTURE

Identifier Type: -

Identifier Source: org_study_id

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