Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture
NCT ID: NCT05947292
Last Updated: 2024-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
114 participants
OBSERVATIONAL
2022-06-01
2024-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Nerve Block
Patients with femur fractures who receive a fascia-iliaca compartment nerve block as part of their care in the Emergency Department.
Ultrasound-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.
No Nerve Block
Patients with femur fractures who receive only intravenous analgesia in the Emergency Department.
No interventions assigned to this group
Interventions
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Ultrasound-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.
Eligibility Criteria
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Inclusion Criteria
* Glasgow Coma Scale of 14 or greater at time of enrollment
Exclusion Criteria
* 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).
4 Years
17 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Medical University of South Carolina
OTHER
Yale University
OTHER
Emory University
OTHER
University of California, San Diego
OTHER
University of California, San Francisco
OTHER
Denver Health and Hospital Authority
OTHER
Children's Hospital of The King's Daughters
OTHER
Gold Coast Hospital and Health Service
OTHER_GOV
Zachary Binder
OTHER
Responsible Party
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Zachary Binder
Assistant Professor
Principal Investigators
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Zachary W Binder, MD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Locations
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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
Countries
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References
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Binder ZW, Ng C, Klekowski N, Lawson SL, Riera A, Toney AG, Pade KH, The TS, Shaahinfar A, Chaudoin LT, Lauer E, Snelling PJ, Moake MM. Ultrasound-Guided Nerve Block for Pediatric Femur Fractures in the Emergency Department: A Prospective Multi-Center Study. Acad Emerg Med. 2025 Jun 17. doi: 10.1111/acem.70084. Online ahead of print.
Other Identifiers
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STUDY00000295
Identifier Type: -
Identifier Source: org_study_id
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