Femur FracturePLEXUSNCT05947292
Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture
An observational study of Femur Fracture, run by Zachary Binder at 10 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Ultrasound-Guided Fascia Iliaca Compartment Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 114 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Jun 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients 4-18 hears of age who present to the Emergency Department with an acute isolated femur fracture.
Who may be able to join
- Acute femur fracture (less than 24 hours from initial injury)
- Glasgow Coma Scale of 14 or greater at time of enrollment
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Medical University of South Carolina
Charleston, South Carolina, 29425
Denver Health and Hospital Authority
Denver, Colorado, 80204
Yale University
New Haven, Connecticut, 06520
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
University of California, San Diego
San Diego, California, 92103
University of California, San Fransisco
San Francisco, California, 94143
UMass
Worcester, Massachusetts, 01655
Australia1 site
Gold Coast Hospital and Health Service
Southport, Queensland, 4215
About this study
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
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.
- Conditions
- Femur Fracture
- Being tested
- Ultrasound-Guided Fascia Iliaca Compartment Nerve Block
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Fascia Iliaca Compartment Nerve BlockProcedure or surgery
Patient's who receive this intervention will have an ultrasound-guided fascia iliaca compartment nerve block performed in the Emergency Department.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Block | Patients with femur fractures who receive a fascia-iliaca compartment nerve block as part of their care in the Emergency Department. Receives: Procedure: Ultrasound-Guided Fascia Iliaca Compartment Nerve Block | |
| No Nerve Block | Patients with femur fractures who receive only intravenous analgesia in the Emergency Department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
60 Minute Pain Score
Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).
Measured: 60 minutes after enrollment.
Secondary outcomes (4)
240 Minute Pain Score
Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).
Measured: 240 minutes after enrollment.
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).
Measured: From admission to the emergency department to hospital discharge, up to 72 hours.
Parental Satisfaction
Participants parents/guardians will be asked to complete a satisfaction survey.
Measured: From admission to the emergency department to discharge from the emergency department, up to 72 hours.
Percentage of Patients Experiencing Adverse Events
Adverse events and complications will be recorded
Measured: From admission to the emergency department to hospital discharge, up to 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Jun 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zachary Binder
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor-investigator, Zachary Binder, University of Massachusetts, Worcester
- Investigators
- Zachary W Binder, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947292
- Sponsor's protocol ID
- STUDY00000295
- Acronym
- PLEXUS
- Status last verified
- Jul 2024
- First submitted
- 14 Jun 2023
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan on sharing data with external researchers.
Publications
Binder ZW, Ng C, Klekowski N, Lawson SL, Riera A, Toney AG, Pade KH, The TS, Shaahinfar A, Chaudoin LT, Lauer E, Snelling PJ, Moake MM. Ultrasound-Guided Nerve Block for Pediatric Femur Fractures in the Emergency Department: A Prospective Multi-Center Study. Acad Emerg Med. 2025 Dec;32(12):1278-1287. doi: 10.1111/acem.70084. Epub 2025 Jun 17.
PubMed 40524602
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05947292
- Acronym / sponsor ID
- PLEXUS / STUDY00000295
- Conditions
- Femur Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Zachary BinderUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Block | – | Procedure: Ultrasound-Guided Fascia Iliaca Compartment Nerve BlockPatients 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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients 4-18 hears of age who present to the Emergency Department with an acute isolated femur fracture.
Key inclusion criteria (2 listed)
- Acute femur fracture (less than 24 hours from initial injury)
- Glasgow Coma Scale of 14 or greater at time of enrollment
Key exclusion criteria (12 listed)
- Allergy or hypersensitivity to local anesthetic agents
- Pregnant
- Prisoner
- Neurovascular injury to the affected limb
- Bilateral femur fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Fascia Iliaca Compartment Nerve BlockPatient's who receive this intervention will have an ultrasound-guided fascia iliaca compartment nerve block performed in the Emergency Department. | Procedure or surgery | Nerve Block |
Primary outcome
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).
4 secondary outcomes
240 Minute Pain Score
Time frame: 240 minutes after enrollment.
Oral Morphine Equivilents
Time frame: 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.
Percentage of Patients Experiencing Adverse Events
Time frame: From admission to the emergency department to hospital discharge, up to 72 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 40524602Binder ZW, Ng C, Klekowski N, Lawson SL, Riera A, Toney AG, Pade KH, The TS, Shaahinfar A, Chaudoin LT, Lauer E, Snelling PJ, Moake MM. Ultrasound-Guided Nerve Block for Pediatric Femur Fractures in the Emergency Department: A Prospective Multi-Center Study. Acad Emerg Med. 2025 Dec;32(12):1278-1287. doi: 10.1111/acem.70084. Epub 2025 Jun 17.
- Individual participant dataSharing planned: No. We do not plan on sharing data with external researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary W Binder, MD principal investigator
University of Massachusetts, Worcester
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture, run by Zachary Binder at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60 Minute Pain Score (time frame: 60 minutes after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05947292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.