Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture

Completed

• Conditions: Femur Fracture

• Registration Number: NCT05947292
• Lead Sponsor: Zachary Binder

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-17
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
60 Minute Pain Score	60 minutes after enrollment.	Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).

Secondary Outcome Measures

Name	Time	Method
Parental Satisfaction	From admission to the emergency department to discharge from the emergency department, up to 72 hours.	Participants parents/guardians will be asked to complete a satisfaction survey.
Oral Morphine Equivilents	From admission to the emergency department to hospital discharge, up to 72 hours.	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).
Percentage of Patients Experiencing Adverse Events	From admission to the emergency department to hospital discharge, up to 72 hours.	Adverse events and complications will be recorded
240 Minute Pain Score	240 minutes after enrollment.	Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).

Trial Locations

Locations (10)

University of California, San Diego; 🇺🇸 San Diego, California, United States

University of California, San Fransisco; 🇺🇸 San Francisco, California, United States

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

UMass; 🇺🇸 Worcester, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Children's Hospital of the King's Daughters; 🇺🇸 Norfolk, Virginia, United States

Gold Coast Hospital and Health Service; 🇦🇺 Southport, Queensland, Australia