search
Back to results

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

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ultrasound-guided femoral nerve block
Intravenous or intramuscular pain medication
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Ultrasound-guided femoral nerve block

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NTUH Yunlin BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Ultrasound-guided femoral nerve block

The liberal use of pain medication

Arm Description

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

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

Outcomes

Primary Outcome Measures

a short time of pain relief
the reduction of pain score

Secondary Outcome Measures

Adverse effects
Any adverse effects of different pain medication
Patient satisfaction
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
Any complications of ultrasound-guided femoral nerve block

Full Information

First Posted
July 23, 2023
Last Updated
July 23, 2023
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05969561
Brief Title
Emergency Physician-performed Ultrasound-guided Femoral Nerve Blocks in Patients With Hip Fractures.
Official Title
Ultrasound-Guided Femoral Nerve Block
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Ultrasound-guided femoral nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided femoral nerve block
Arm Type
Active Comparator
Arm Description
Patients with hip fractures had underwent Ultrasound-guided femoral nerve block performed by emergency physicians.
Arm Title
The liberal use of pain medication
Arm Type
Sham Comparator
Arm Description
Patients with hip fractures had given intravenous or intramuscular opioids or NSAID at the emergency department.
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided femoral nerve block
Intervention Description
The local analgesia is injected and infiltrated around the femoral nerve under ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
Intravenous or intramuscular pain medication
Intervention Description
Intravenous or intramuscular pain medication is given for patients with hip fracture.
Primary Outcome Measure Information:
Title
a short time of pain relief
Description
the reduction of pain score
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Adverse effects
Description
Any adverse effects of different pain medication
Time Frame
two hours
Title
Patient satisfaction
Description
The difference of patient satisfaction between ultrasound-guided femoral nerve block and the liberal use of pain medication
Time Frame
two hours
Title
Complications of ultrasound-guided femoral nerve block
Description
Any complications of ultrasound-guided femoral nerve block
Time Frame
two hours and one week after ultrasound-guided femoral nerve block or after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YILIN LEE
Phone
+886972655633
Email
leeatntuh@gmail.com
Facility Information:
Facility Name
NTUH Yunlin Branch
City
Douliu
State/Province
Yunlin County
ZIP/Postal Code
640
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YILIN LEE
Phone
+886972655633
Email
leeatntuh@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs