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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05947292
Other study ID # STUDY00000295
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date June 2025

Study information

Verified date July 2023
Source University of Massachusetts, Worcester
Contact Zachary W Binder, MD
Phone 617-755-7737
Email Zachary.Binder@umassmemorial.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this prospective observational study is to compare pain control strategies in children with femur fractures. Researchers will compare ultrasound-guided fascia iliaca compartment nerve block to IV pain control alone. The main questions it aims to answer are: - Are ultrasound-guided fascia iliaca compartment nerve blocks as effective as IV pain control in controlling pain? - Do patients who receive an ultrasound-guided fascia iliaca compartment nerve block require less opioid pain medication than those that don't? Participants will be asked to provide pain scores during their Emergency Department stay. Participants parents will be asked to complete a brief survey at the time their child is leaving the Emergency Department.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2025
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility Inclusion Criteria: - Acute femur fracture (less than 24 hours from initial injury) - Glasgow Coma Scale of 14 or greater at time of enrollment Exclusion Criteria: - Allergy or hypersensitivity to local anesthetic agents - Pregnant - Prisoner - Neurovascular injury to the affected limb - Bilateral femur fractures - Confirmed, or significant clinical suspicion for, injury to their head, neck, chest, abdomen, back or pelvis - Imaging suggestive of a head, neck, chest, abdomen, back or pelvic injury - Laboratory results suggestive of a head, neck, chest, abdomen, back or pelvic injury - A fracture not limited to the extremities (i.e. vertebral compression fracture) - A significantly displaced extremity fractures (aside from the primary femur fracture) - An open fracture (aside from the primary femur fracture) - An additional fracture to the limb of the primary femur fracture (i.e. tibia fracture in the same leg as the primary femur fracture).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound-Guided Fascia Iliaca Compartment Nerve Block
Patient's who receive this intervention will have an ultrasound-guided fascia iliaca compartment nerve block performed in the Emergency Department.

Locations

Country Name City State
Australia Gold Coast Hospital and Health Service Southport Queensland
United States University of Michigan Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States Medical University of South Carolina Charleston South Carolina
United States Denver Health and Hospital Authority Denver Colorado
United States Yale University New Haven Connecticut
United States Children's Hospital of the King's Daughters Norfolk Virginia
United States University of California, San Diego San Diego California
United States University of California, San Fransisco San Francisco California
United States UMass Worcester Massachusetts

Sponsors (10)

Lead Sponsor Collaborator
Zachary Binder Children's Hospital of The King's Daughters, Denver Health and Hospital Authority, Emory University, Gold Coast Hospital and Health Service, Medical University of South Carolina, University of California, San Diego, University of California, San Francisco, University of Michigan, Yale University

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 60 Minute Pain Score Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome). 60 minutes after enrollment.
Secondary 240 Minute Pain Score Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome). 240 minutes after enrollment.
Secondary Oral Morphine Equivilents Opioid medications received. All opioids will be converted to oral morphine equivilents using the opioid equianalgesic calculator developed the Faculty of Pain Medicine, Australian and New Zealand College of Anesthetists (FPM ANZCA). From admission to the emergency department to hospital discharge, up to 72 hours.
Secondary Parental Satisfaction Participants parents/guardians will be asked to complete a satisfaction survey. From admission to the emergency department to discharge from the emergency department, up to 72 hours.
Secondary Percentage of Patients Experiencing Adverse Events Adverse events and complications will be recorded From admission to the emergency department to hospital discharge, up to 72 hours.
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