Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-26 @ 9:01 AM
Study NCT ID:
NCT05947292
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2023-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '60 Minute Pain Score', 'timeFrame': '60 minutes after enrollment.', 'description': 'Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).'}], 'secondaryOutcomes': [{'measure': '240 Minute Pain Score', 'timeFrame': '240 minutes after enrollment.', 'description': 'Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).'}, {'measure': 'Oral Morphine Equivilents', 'timeFrame': 'From admission to the emergency department to hospital discharge, up to 72 hours.', 'description': '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).'}, {'measure': 'Parental Satisfaction', 'timeFrame': 'From admission to the emergency department to discharge from the emergency department, up to 72 hours.', 'description': 'Participants parents/guardians will be asked to complete a satisfaction survey.'}, {'measure': 'Percentage of Patients Experiencing Adverse Events', 'timeFrame': 'From admission to the emergency department to hospital discharge, up to 72 hours.', 'description': 'Adverse events and complications will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Femur Fracture']}, 'referencesModule': {'references': [{'pmid': '40524602', 'type': 'DERIVED', 'citation': '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 Jun 17. doi: 10.1111/acem.70084. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "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:\n\n* Are ultrasound-guided fascia iliaca compartment nerve blocks as effective as IV pain control in controlling pain?\n* Do patients who receive an ultrasound-guided fascia iliaca compartment nerve block require less opioid pain medication than those that don't?\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 4-18 hears of age who present to the Emergency Department with an acute isolated femur fracture.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute femur fracture (less than 24 hours from initial injury)\n* Glasgow Coma Scale of 14 or greater at time of enrollment\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to local anesthetic agents\n* Pregnant\n* Prisoner\n* Neurovascular injury to the affected limb\n* Bilateral femur fractures\n* Confirmed, or significant clinical suspicion for, injury to their head, neck, chest, abdomen, back or pelvis\n* Imaging suggestive of a head, neck, chest, abdomen, back or pelvic injury\n* Laboratory results suggestive of a head, neck, chest, abdomen, back or pelvic injury\n* A fracture not limited to the extremities (i.e. vertebral compression fracture)\n* A significantly displaced extremity fractures (aside from the primary femur fracture)\n* An open fracture (aside from the primary femur fracture)\n* An additional fracture to the limb of the primary femur fracture (i.e. tibia fracture in the same leg as the primary femur fracture).'}, 'identificationModule': {'nctId': 'NCT05947292', 'acronym': 'PLEXUS', 'briefTitle': 'Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'STUDY00000295'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nerve Block', 'description': 'Patients with femur fractures who receive a fascia-iliaca compartment nerve block as part of their care in the Emergency Department.', 'interventionNames': ['Procedure: Ultrasound-Guided Fascia Iliaca Compartment Nerve Block']}, {'label': 'No Nerve Block', 'description': 'Patients with femur fractures who receive only intravenous analgesia in the Emergency Department.'}], 'interventions': [{'name': 'Ultrasound-Guided Fascia Iliaca Compartment Nerve Block', 'type': 'PROCEDURE', 'description': "Patient's who receive this intervention will have an ultrasound-guided fascia iliaca compartment nerve block performed in the Emergency Department.", 'armGroupLabels': ['Nerve Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Fransisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health and Hospital Authority', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': "Children's Hospital of the King's Daughters", 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast Hospital and Health Service', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}], 'overallOfficials': [{'name': 'Zachary W Binder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not plan on sharing data with external researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zachary Binder', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}, {'name': 'Emory University', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'Denver Health and Hospital Authority', 'class': 'OTHER'}, {'name': "Children's Hospital of The King's Daughters", 'class': 'OTHER'}, {'name': 'Gold Coast Hospital and Health Service', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zachary Binder', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}