NCT05969561

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 5, 2025

Status Verified

June 1, 2025

Enrollment Period

1.7 years

First QC Date

July 23, 2023

Last Update Submit

July 31, 2025

Conditions

Keywords

Ultrasound-guided femoral nerve block

Outcome Measures

Primary Outcomes (1)

  • a short time of pain relief

    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.

    2 hours

Secondary Outcomes (3)

  • 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

Study Arms (2)

Ultrasound-guided femoral nerve block

ACTIVE COMPARATOR

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

Procedure: ultrasound-guided femoral nerve block

The liberal use of pain medication

SHAM COMPARATOR

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

Drug: Intravenous or intramuscular pain medication

Interventions

The local analgesia is injected and infiltrated around the femoral nerve under ultrasound guidance.

Ultrasound-guided femoral nerve block

Intravenous or intramuscular pain medication is given for patients with hip fracture.

The liberal use of pain medication

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH Yunlin Branch

Douliu, Yunlin County, 640, Taiwan

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

July 3, 2023

Primary Completion

March 5, 2025

Study Completion

December 30, 2025

Last Updated

August 5, 2025

Record last verified: 2025-06

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