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

Study Overview
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Brief Summary
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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.

Official Title
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PLEXUS (Pediatric Lower Extremity Ultrasound-Guided Nerve Block) Study: A Prospective, Multi-center, Observational Study Comparing Ultrasound Guided Fascia Iliaca Compartment Nerve Block to Systemic Analgesia for Femur Fractures in the Pediatric Emergency Department

Conditions
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Femur Fracture

Intervention / Treatment
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* Procedure: Ultrasound-Guided Fascia Iliaca Compartment Nerve Block


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nerve Block<br>Patients with femur fractures who receive a fascia-iliaca compartment nerve block as part of their care in the Emergency Department. | Procedure: Ultrasound-Guided Fascia Iliaca Compartment Nerve Block<br>* Patient's who receive this intervention will have an ultrasound-guided fascia iliaca compartment nerve block performed in the Emergency Department.<br>|
| No Nerve Block<br>Patients with femur fractures who receive only intravenous analgesia in the Emergency Department. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. |