Skip to main content
OpenTrials
Completed

NCT Number: NCT05947292

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Femur Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gold Coast Hospital and Health Service, Southport, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 60 Minute Pain Score

    Time frame: 60 minutes after enrollment.

    Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).

Secondary outcomes

  1. 240 Minute Pain Score

    Time frame: 240 minutes after enrollment.

    Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).

  2. Oral Morphine Equivilents

    Time frame: From 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).

  3. Parental Satisfaction

    Time frame: From 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.

  4. Percentage of Patients Experiencing Adverse Events

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

    Adverse events and complications will be recorded

Sponsors and collaborators

Lead sponsor

Zachary Binder

Other

Collaborators

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

Registry information

Official study 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

Acronym: PLEXUS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2023
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.