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

Hip Fractures Clinical Trial

Official title:

Ultrasound-Guided Femoral Nerve Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05969561
• Other study ID #: 202211021RINB
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: National Taiwan University Hospital
• Contact: YILIN LEE
• Phone: +886972655633
• Email: leeatntuh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Fractures

Intervention

Procedure:
• ultrasound-guided femoral nerve block
The local analgesia is injected and infiltrated around the femoral nerve under ultrasound guidance.

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

Locations

Country	Name	City	State
Taiwan	NTUH Yunlin Branch	Douliu	Yunlin County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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