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

September 26, 2016 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • CHUVaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fascia iliaca block
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
injection of 30 mLs below the fascia iliaca
Sham Comparator: Sham injection
No fascia iliaca block (Sham injection = Subcutaneous injection of 5 cc of normal saline, no intervention)
Procedure: Sham injection
subcutaneous of 5 cc of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain scores at rest
Time Frame: 45 minutes after the injection
45 minutes after the injection

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Eric Albrecht, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 318/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Femoral Neck Fracture

Clinical Trials on Fascia iliaca block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe