Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase

September 13, 2006 updated by: Hvidovre University Hospital
To evaluate the analgesic potential of an neural blockade (Fascia iliaca compartment) with local anaesthetics in patients with hip fracture immediately after arrival in the emergency department.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hip fracture patients have severe pain in the acute phase. Traditional analgesic treatment have consisted of intramuscular morphine with its associated side effects. The trial evaluates the Fascia iliaca compartment compared to regular opioid pain therapy in hip fracture patinets immediately after arrival at the emergency department.

Study Type

Interventional

Enrollment

48

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

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary hip fracture suspected
  • able to give informed consent
  • no substance abuse
  • no regular opioid therapy
  • no opioid treatment within the last 6 hours
  • morphine intolerance
  • allergies to local anaesthetics

Exclusion Criteria:

  • Fracture ruled out on x-ray

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain relief within 3 hours

Secondary Outcome Measures

Outcome Measure
Nausea
Pain on transfer
Discomfort with block placement

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Collaborators

IMK Fonden

Investigators

  • Study Director: Nicolai B Foss, MD, Hvidovre University Hospital

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

May 1, 2003

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2006

Last Update Submitted That Met QC Criteria

September 13, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHSG-rct-04

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.

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