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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06296758
Other study ID # SiFi_HIP FRACTURE
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2026

Study information

Verified date February 2024
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 106
Est. completion date May 1, 2026
Est. primary completion date May 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Canada University of Alberta Hospital Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain Postoperative numerical pain rating scale (NRS) pain scores 48 hours
Primary Postoperative analgesics administered Postoperative opioid utilization 48 hours
Secondary Mobilization Time to first mobilization 48 hours
Secondary Time to readiness for discharge Time to 'ready for discharge' 48 hours
Secondary Complications Complications associated with both block techniques 48 hours
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