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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05947292
Acronym
PLEXUS
Enrollment
114
Registered
2023-07-17
Start date
2022-06-01
Completion date
2024-06-30
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

PROCEDUREUltrasound-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.

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
60 Minute Pain Score60 minutes after enrollment.Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).

Secondary

MeasureTime frameDescription
240 Minute Pain Score240 minutes after enrollment.Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).
Oral Morphine EquivilentsFrom 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).
Parental SatisfactionFrom 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.
Percentage of Patients Experiencing Adverse EventsFrom admission to the emergency department to hospital discharge, up to 72 hours.Adverse events and complications will be recorded

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026