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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05969561

Collaborator

(none)

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures	Procedure: ultrasound-guided femoral nerve block Drug: Intravenous or intramuscular pain medication	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ultrasound-Guided Femoral Nerve Block

Actual Study Start Date :

Jul 3, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

a short time of pain relief [2 hours]
the reduction of pain score

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NTUH Yunlin Branch	Douliu	Yunlin County	Taiwan	640

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT05969561

Other Study ID Numbers:

202211021RINB

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

Ultrasound-guided femoral nerve block

Additional relevant MeSH terms:

Hip Fractures

Analgesics

Study Results

No Results Posted as of Aug 1, 2023