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

Z

Zachary Binder

Status

Completed

Conditions

Femur Fracture

Treatments

Procedure: Ultrasound-Guided Fascia Iliaca Compartment Nerve Block

Study type

Observational

Funder types

Other

Identifiers

NCT05947292
STUDY00000295

Details and patient eligibility

About

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.

Enrollment

114 patients

Sex

All

Ages

4 to 17 years old

Volunteers

No Healthy Volunteers

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).

Trial design

114 participants in 2 patient groups

Nerve Block
Description:
Patients with femur fractures who receive a fascia-iliaca compartment nerve block as part of their care in the Emergency Department.
Treatment:
Procedure: Ultrasound-Guided Fascia Iliaca Compartment Nerve Block
No Nerve Block
Description:
Patients with femur fractures who receive only intravenous analgesia in the Emergency Department.

Trial contacts and locations

10

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Central trial contact

Zachary W Binder, MD

Data sourced from clinicaltrials.gov

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