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Completed

NCT Number: NCT02433548

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

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.

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Key information

Conditions

Femoral Neck Fracture Agnosia Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHUVaudois

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fascia iliaca block

Procedure

injection of 30 mLs below the fascia iliaca

Sham injection

Procedure

subcutaneous of 5 cc of normal saline

Primary outcomes

  1. Pain scores at rest

    Time frame: 45 minutes after the injection

Secondary outcomes

  1. Pain scores at rest

    Time frame: 60 min, 4h, 8h, 12h, 24h after the injection

  2. Pain scores on movement

    Time frame: 60 min, 4h, 8h, 12h, 24h after the injection

  3. Morphine consumption

    Time frame: 60 min, 4h, 8h, 12h, 24h after the injection

  4. Length of stay

    Time frame: up to 3 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 5, 2015
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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