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

Femoral Neck Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433548
• Other study ID #: 318/14
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2014
• Last updated: September 26, 2016
• Start date: October 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Fascia iliaca block
injection of 30 mLs below the fascia iliaca
• Sham injection
subcutaneous of 5 cc of normal saline

Locations

Country	Name	City	State
Switzerland	CHUVaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores at rest		45 minutes after the injection	No
Secondary	Pain scores at rest		60 min, 4h, 8h, 12h, 24h after the injection	No
Secondary	Pain scores on movement		60 min, 4h, 8h, 12h, 24h after the injection	No
Secondary	Morphine consumption		60 min, 4h, 8h, 12h, 24h after the injection	No
Secondary	Length of stay		up to 3 weeks	No