Emergency Physician-performed Ultrasound-guided Femoral Nerve Blocks in Patients With Hip Fractures.

July 23, 2023 updated by: National Taiwan University Hospital

Ultrasound-Guided Femoral Nerve Block

In this prospective study, emergency physicians perform ultrasound-guided femoral nerve block for patients with hip fractures. We compare the effectiveness of analgesia and patient satisfaction of ultrasound-guided femoral nerve block with liberal use of the pain medication in the emergency department. The primary outcome is the assessment of time to relief the pain with fewer adverse effects and less rescue pain medication use. The secondary outcome is patient satisfaction with pain management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact

Study Locations

  • Taiwan
    • Yunlin County
      • Douliu, Yunlin County, Taiwan, 640
        • Recruiting
        • NTUH Yunlin branch
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients older than 20-year-old with hip fractures
  • Stay in the emergency department for at lease two hours

Exclusion Criteria:

  • hemodynamic unstable
  • major trauma in addition to hip fractures
  • the use of any pain management before the arrival of emergency department
  • chronic opioid use
  • inability to understood the numerical rating scale after instruction
  • allergy to local anesthetics
  • coagulopathy
  • injection site infection

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-guided femoral nerve block
Patients with hip fractures had underwent Ultrasound-guided femoral nerve block performed by emergency physicians.
Procedure: ultrasound-guided femoral nerve block
The local analgesia is injected and infiltrated around the femoral nerve under ultrasound guidance.
Sham Comparator: The liberal use of pain medication
Patients with hip fractures had given intravenous or intramuscular opioids or NSAID at the emergency department.
Drug: Intravenous or intramuscular pain medication
Intravenous or intramuscular pain medication is given for patients with hip fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a short time of pain relief
Time Frame: 2 hours
the reduction of pain score
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: two hours
Any adverse effects of different pain medication
two hours
Patient satisfaction
Time Frame: two hours
The difference of patient satisfaction between ultrasound-guided femoral nerve block and the liberal use of pain medication
two hours
Complications of ultrasound-guided femoral nerve block
Time Frame: two hours and one week after ultrasound-guided femoral nerve block or after hospital discharge
Any complications of ultrasound-guided femoral nerve block
two hours and one week after ultrasound-guided femoral nerve block or after hospital discharge

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

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 (Actual)

July 3, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202211021RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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