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

• Sponsor: Zachary Binder (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05947292
• Collaborator: 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)
• Enrollment: 60
• Locations: 10
• Anticipated Duration (Months): 36
• Patients Per Site: 6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Femur Fracture	Procedure: Ultrasound-Guided Fascia Iliaca Compartment Nerve Block

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 60 Minute Pain Score [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 Outcome Measures

1. 240 Minute Pain Score [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 [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 [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 [From admission to the emergency department to hospital discharge, up to 72 hours.]

   Adverse events and complications will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	San Diego	California	United States	92103
2	University of California, San Fransisco	San Francisco	California	United States	94143
3	Denver Health and Hospital Authority	Denver	Colorado	United States	80204
4	Yale University	New Haven	Connecticut	United States	06520
5	Emory University	Atlanta	Georgia	United States	30322
6	UMass	Worcester	Massachusetts	United States	01655
7	University of Michigan	Ann Arbor	Michigan	United States	48109
8	Medical University of South Carolina	Charleston	South Carolina	United States	29425
9	Children's Hospital of the King's Daughters	Norfolk	Virginia	United States	23507
10	Gold Coast Hospital and Health Service	Southport	Queensland	Australia	4215

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zachary Binder, Assistant Professor, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT05947292
• Other Study ID Numbers: STUDY00000295
• First Posted: Jul 17, 2023
• Last Update Posted: Jul 17, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fractures, Bone; Femoral Fractures

Study Results

No Results Posted as of Jul 17, 2023