- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05969561
Emergency Physician-performed Ultrasound-guided Femoral Nerve Blocks in Patients With Hip Fractures.
Ultrasound-Guided Femoral Nerve Block
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: YILIN LEE
- Phone Number: +886972655633
- Email: leeatntuh@gmail.com
Study Locations
-
-
Yunlin County
-
Douliu, Yunlin County, Taiwan, 640
- Recruiting
- NTUH Yunlin Branch
-
Contact:
- YILIN LEE
- Phone Number: +886972655633
- Email: leeatntuh@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Intravenous or intramuscular pain medication is given for patients with hip fracture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse effects
Time Frame: two hours
|
Any adverse effects of different pain medication
|
two hours
|
|
Patient satisfaction
Time Frame: two hours
|
The difference of patient satisfaction between ultrasound-guided femoral nerve block and the liberal use of pain medication
|
two hours
|
|
Complications of ultrasound-guided femoral nerve block
Time Frame: two hours and one week after ultrasound-guided femoral nerve block or after hospital discharge
|
Any complications of ultrasound-guided femoral nerve block
|
two hours and one week after ultrasound-guided femoral nerve block or after hospital discharge
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202211021RINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
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Smith & Nephew, Inc.Terminated
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Medical Centre LeeuwardenNot yet recruitingHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)Netherlands
-
San Giovanni di Dio HospitalRecruitingHip Surgery | Hip ArthroplastyItaly
-
Gaziantep City HospitalCompletedFemoral Neck Fractures | Hip SurgeryTurkey (Türkiye)
-
Carilion ClinicCompleted
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Sheffield Teaching Hospitals NHS Foundation TrustRecruitingHip FractureUnited Kingdom
-
JointResearchRecruitingHip Fractures (ICD-10 72.01-72.2)Netherlands
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
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Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
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