Clinical trial NCT05947292: Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Fracture
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Medical University of South Carolina
name: Yale University
name: Emory University
name: University of California, San Diego
name: University of California, San Francisco
name: Denver Health and Hospital Authority
name: Children's Hospital of The King's Daughters
name: Gold Coast Hospital and Health Service
First posted: 2023-07-17
Enrollment: 114
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 4-18 hears of age who present to the Emergency Department with an acute isolated femur fracture.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 60 Minute Pain Score
timeFrame: 60 minutes after enrollment.
Secondary outcomes:
measure: 240 Minute Pain Score
timeFrame: 240 minutes after enrollment.
measure: Oral Morphine Equivilents
timeFrame: From admission to the emergency department to hospital discharge, up to 72 hours.
measure: Parental Satisfaction
timeFrame: From admission to the emergency department to discharge from the emergency department, up to 72 hours.
measure: Percentage of Patients Experiencing Adverse Events
timeFrame: From admission to the emergency department to hospital discharge, up to 72 hours.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Fransisco
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Worcester
country: United States
facility: UMass
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Southport
country: Australia
facility: Gold Coast Hospital and Health Service
state: Queensland
Study officials:
affiliation: University of Massachusetts, Worcester
name: Zachary W Binder, MD
role: PRINCIPAL_INVESTIGATOR
References: