Femur Fracture Clinical Trial
— PLEXUSOfficial 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
NCT number | NCT05947292 |
Other study ID # | STUDY00000295 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | June 2025 |
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.
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). |
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 |
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 |
United States, Australia,
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. |
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