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

July 12, 2023 updated by: Zachary Binder

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
  • United States
    • California
      • San Diego, California, United States, 92103
      • San Francisco, California, United States, 94143
    • Colorado
      • Denver, Colorado, United States, 80204
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
60 minutes after enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
240 minutes after enrollment.
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).
From admission to the emergency department to hospital discharge, up to 72 hours.
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.
From admission to the emergency department to discharge from the emergency department, up to 72 hours.
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
From admission to the emergency department to hospital discharge, up to 72 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zachary Binder

Collaborators

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

Investigators

  • Principal Investigator: Zachary W Binder, MD, University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan on sharing data with external researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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