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

NCT05947292 | Completed

• 1 other identifier: STUDY00000295
• Study Type: observational
• Target: 114
• Locations: 2 countries
• Sites: 10

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.

Conditions

Femur Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 240 Minute Pain Score

  240 minutes after enrollment.

• Oral Morphine Equivilents

  From admission to the emergency department to hospital discharge, up to 72 hours.

• Parental Satisfaction

  From admission to the emergency department to discharge from the emergency department, up to 72 hours.

• Percentage of Patients Experiencing Adverse Events

  From admission to the emergency department to hospital discharge, up to 72 hours.

Study Arms (2)

Nerve Block

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

No Nerve Block

Patients with femur fractures who receive only intravenous analgesia in the Emergency Department.

Interventions

Ultrasound-Guided Fascia Iliaca Compartment Nerve Block PROCEDURE

Patient's who receive this intervention will have an ultrasound-guided fascia iliaca compartment nerve block performed in the Emergency Department.

Nerve Block

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Acute femur fracture (less than 24 hours from initial injury)
• Glasgow Coma Scale of 14 or greater at time of enrollment

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zachary Binder: lead
• University of Michigan: collaborator
• Medical University of South Carolina: collaborator
• Yale University: collaborator
• Emory University: collaborator
• University of California, San Diego: collaborator
• University of California, San Francisco: collaborator
• Denver Health and Hospital Authority: collaborator
• Children's Hospital of The King's Daughters: collaborator
• Gold Coast Hospital and Health Service: collaborator

Study Sites (10)

University of California, San Diego

San Diego, California, 92103, United States

Location

University of California, San Fransisco

San Francisco, California, 94143, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

UMass

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Gold Coast Hospital and Health Service

Southport, Queensland, 4215, Australia

Location

Related Publications (1)

• 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 Dec;32(12):1278-1287. doi: 10.1111/acem.70084. Epub 2025 Jun 17.

  PMID: 40524602 DERIVED

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Zachary W Binder, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 17, 2023
• Study Start: June 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (9)