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

Femur Fracture Clinical Trial

— PLEXUS  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947292
• Other study ID #: STUDY00000295
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: University of Massachusetts, Worcester
• Contact: Zachary W Binder, MD
• Phone: 617-755-7737
• Email: Zachary.Binder[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

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.

Locations

Country	Name	City	State
Australia	Gold Coast Hospital and Health Service	Southport	Queensland
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Yale University	New Haven	Connecticut
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	University of California, San Diego	San Diego	California
United States	University of California, San Fransisco	San Francisco	California
United States	UMass	Worcester	Massachusetts

Sponsors (10)

Lead Sponsor	Collaborator
Zachary Binder	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

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	240 Minute Pain Score	Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).	240 minutes after enrollment.
Secondary	Oral Morphine Equivilents	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.
Secondary	Parental Satisfaction	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.
Secondary	Percentage of Patients Experiencing Adverse Events	Adverse events and complications will be recorded	From admission to the emergency department to hospital discharge, up to 72 hours.