Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia

January 15, 2014 updated by: Maria Diakomi, Asklepieion Voulas General Hospital

Fascia Iliaca Compartment Block Versus Fentanyl for Positioning Patients With Hip Fractures for Central Nervous Blockade: a Randomized Trial.

The purpose of this study is to compare two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

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

  • Greece
    • Attica
      • Athens, Attica, Greece, 16673
        • Asklepieion Hospital of Voula

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hip fracture

Exclusion Criteria:

  • contraindications for central nervous blockade
  • impaired cognition or dementia
  • multiple fractures
  • any previous analgesic administration during the last 12 hours

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fentanyl
Drug: Fentanyl
Fentanyl IV
Active Comparator: Fascia iliaca compartment block
Drug: ropivacaine
Procedure: Fascia iliaca compartment block
Fascia iliaca compartment block using ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain scores on the Numeric Rating Scale
Time Frame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of spinal anesthesia performance
Time Frame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Quality of patient's position
Time Frame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)

Collaborators and Investigators

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

Sponsor

Asklepieion Voulas General 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

July 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 12, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 478-9227/25-7-2012

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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