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Clinical Trials/NCT05969561
NCT05969561RecruitingNot Applicable

Ultrasound-Guided Femoral Nerve Block

National Taiwan University Hospital1 site in 1 country80 target enrollmentStarted: July 3, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
80
Locations
1
Primary Endpoint
a short time of pain relief

Study Overview

Brief Summary

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 medicine 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 and adverse effects for different method of pain control.

Detailed Description

The aim of this study is to compare the effectiveness of ultrasound-guided femoral nerve blocks performed by emergency physicians for pain control in the emergency department with traditional pain medicine.

This study is a prospective before-and-after design. The enrollees are 20-year-old and older adult patients with hip fractures. We use numerical rating scale using a 0-10 scale to assess pain severity at the different time frame after giving pain medicine. The scale zero means "no pain" and scale 10 means "the worst pain imaginable".

The primary outcome is assessed by the reduction of pain scale which are taken on a numeric rating scale every 30 minutes before and after pain management. The secondary outcome compares complications, adverse effects and patient satisfaction for different method of pain control.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Ultrasound-guided femoral nerve block

Active Comparator

Patients with hip fractures had underwent Ultrasound-guided femoral nerve block performed by emergency physicians.

Intervention: ultrasound-guided femoral nerve block (Procedure)

The liberal use of pain medication

Sham Comparator

Patients with hip fractures had given intravenous or intramuscular opioids or NSAID at the emergency department.

Intervention: Intravenous or intramuscular pain medication (Drug)

Outcomes

Primary Outcomes

a short time of pain relief

Time Frame: 2 hours

The numerical pain score from 0 to 10 is used to assess pain severity and the scale 0 means no pain and the scale 10 means the worst pain imaginable. The pain score assessed for the leg with hip fracture at rest and with movement will be recorded after different pain medicine and the reduction of pain score at different time frame will be evaluated. The more reduction of pain score, the better.

Secondary Outcomes

  • Adverse effects(two hours)
  • Patient satisfaction(two hours)
  • Complications of ultrasound-guided femoral nerve block(two hours and one week after ultrasound-guided femoral nerve block or after hospital discharge)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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