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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05947292




Registration number
NCT05947292
Ethics application status
Date submitted
14/06/2023
Date registered
17/07/2023
Date last updated
29/07/2024

Titles & IDs
Public title
Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture
Scientific 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
Secondary ID [1] 0 0
STUDY00000295
Universal Trial Number (UTN)
Trial acronym
PLEXUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femur Fracture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Ultrasound-Guided Fascia Iliaca Compartment Nerve Block

Nerve Block - Patients with femur fractures who receive a fascia-iliaca compartment nerve block as part of their care in the Emergency Department.

No Nerve Block - Patients with femur fractures who receive only intravenous analgesia in the Emergency Department.


Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
60 Minute Pain Score
Timepoint [1] 0 0
60 minutes after enrollment.
Secondary outcome [1] 0 0
240 Minute Pain Score
Timepoint [1] 0 0
240 minutes after enrollment.
Secondary outcome [2] 0 0
Oral Morphine Equivilents
Timepoint [2] 0 0
From admission to the emergency department to hospital discharge, up to 72 hours.
Secondary outcome [3] 0 0
Parental Satisfaction
Timepoint [3] 0 0
From admission to the emergency department to discharge from the emergency department, up to 72 hours.
Secondary outcome [4] 0 0
Percentage of Patients Experiencing Adverse Events
Timepoint [4] 0 0
From admission to the emergency department to hospital discharge, up to 72 hours.

Eligibility
Key inclusion criteria
* Acute femur fracture (less than 24 hours from initial injury)
* Glasgow Coma Scale of 14 or greater at time of enrollment
Minimum age
4 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2024
Sample size
Target
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast Hospital and Health Service - Southport
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Other
Name
Zachary Binder
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Michigan
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Medical University of South Carolina
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Yale University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Emory University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of California, San Diego
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of California, San Francisco
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Denver Health and Hospital Authority
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Children's Hospital of The King's Daughters
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Government body
Name [9] 0 0
Gold Coast Hospital and Health Service
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05947292
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zachary W Binder, MD
Address 0 0
University of Massachusetts, Worcester
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zachary W Binder, MD
Address 0 0
Country 0 0
Phone 0 0
617-755-7737
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05947292