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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Femoral Neck Fracture

Intervention / Treatment
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* Procedure: Fascia iliaca block
* Procedure: Sham injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fascia iliaca block<br>Fascia iliaca block (Injection of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL below the fascia iliaca, Carbostesin®) | Procedure: Fascia iliaca block<br>* injection of 30 mLs below the fascia iliaca<br>|
| Sham Comparator: Sham injection<br>No fascia iliaca block (Sham injection = Subcutaneous injection of 5 cc of normal saline, no intervention) | Procedure: Sham injection<br>* subcutaneous of 5 cc of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores at rest |  | 45 minutes after the injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Morphine consumption |  | 60 min, 4h, 8h, 12h, 24h after the injection | 
| Length of stay |  | up to 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Regional, Analgesia, Emergency medicine