Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture

Phase 4

Completed

• Conditions: Femoral Neck Fracture
• Interventions: Procedure: Fascia iliaca block; Procedure: Sham injection

• Registration Number: NCT02433548
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

Femoral neck fracture is very common in the elderly and can produce severe to moderate pain. As this pathology is not life-threatening, waiting time in the emergency department may be prolonged due to the high number of unforeseen cases with patients remaining in pain.

Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca, resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves, with effective analgesia.

Detailed Description

The objective of this trial is to compare the fascia iliaca block with a sham injection on patients arriving in the emergency department with a femoral neck fracture.

The fascia iliaca block will be performed with an anatomical landmark technique and a volume of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL will be injected.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients with femoral neck fracture in the emergency department

Exclusion Criteria

• presence of demencia
• body weight less than 40kg
• presence of a cancer or patients receiving chemotherapy
• allergy to local anaesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fascia iliaca block	Fascia iliaca block	Fascia iliaca block (Injection of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL below the fascia iliaca, Carbostesin®)
Sham injection	Sham injection	No fascia iliaca block (Sham injection = Subcutaneous injection of 5 cc of normal saline, no intervention)

Primary Outcome Measures

Name	Time	Method
Pain scores at rest	45 minutes after the injection

Secondary Outcome Measures

Name	Time	Method
Pain scores at rest	60 min, 4h, 8h, 12h, 24h after the injection
Pain scores on movement	60 min, 4h, 8h, 12h, 24h after the injection
Length of stay	up to 3 weeks
Morphine consumption	60 min, 4h, 8h, 12h, 24h after the injection

Trial Locations

Locations (1)

CHUVaudois; 🇨🇭 Lausanne, Vaud, Switzerland