Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05102760
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2021-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PENG vs. FIC Block for Hip Fracture ED Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-18', 'size': 190453, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-20T11:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score at 30 Minutes', 'timeFrame': '30 minutes post administration of nerve block', 'description': 'The pain score at 11 point Likert Scale ranging 0 (no pain) to 10 (very severe pain) at 30 minutes post nerve block procedure'}], 'secondaryOutcomes': [{'measure': 'Pain Score at 60 minutes', 'timeFrame': '60 minutes post administration of nerve block', 'description': 'The pain score at 11 point Likert Scale ranging 0 (no pain) to 10 (very severe pain) at 60 minutes post nerve block procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Hip Fracture', 'Nerve Block', 'Ultrasound'], 'conditions': ['Pain', 'Hip Fracture']}, 'descriptionModule': {'briefSummary': 'Ultrasound-guided nerve blocks are an important tool for treating pain due to orthopedic injury in the ED. They provide long lasting, opioid-sparing pain relief that is generally safe and well-tolerated by patients1. Elderly patients with hip fractures commonly present to the ED, and their injury can be painful. Commonly used opioid pain regimens can have deleterious side effects, especially in elderly patients, like somnolence, delirium, hypotension and respiratory depression.\n\nThe fascia iliaca compartment (FIC) block has become a familiar technique to emergency physicians as a pain control treatment for hip fractures. The pericapsular nerve group (PENG) block has recently been proposed as a novel method to treat pain due to hip, acetabular and pelvic fracture by targeting the terminal sensory articular nerve branches of the femoral nerve (FN), obturator nerve (ON), and accessory obturator nerve (AON). At this time there has been no study comparing the efficacy of the two nerve blocks, PENG and FIC.\n\nThis aim of this study is to compare the efficacy of the PENG block (20mL of Bupivacaine 0.50%) to that of the FIC block (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED. Our hypothesis is that PENG will demonstrate analgesia that is non-inferior to FIC. Subjective pain scores on a scale of 0 to 10 will be assessed before and after the block. All subjects will receive 4mg of morphine after consent and prior to the block.', 'detailedDescription': "Ultrasound-guided nerve blocks are an important tool for treating pain due to orthopedic injury in the ED. They provide long lasting, opioid-sparing pain relief that is generally safe and well-tolerated by patients1. Elderly patients with hip fractures commonly present to the ED, and their injury can be painful. Commonly used opioid pain regimens can have deleterious side effects, especially in elderly patients, like somnolence, delirium, hypotension and respiratory depression.\n\nThe fascia iliaca compartment (FIC) block has become a familiar technique to emergency physicians as a pain control treatment for hip fractures. The pericapsular nerve group (PENG) block has recently been proposed as a novel method to treat pain due to hip, acetabular and pelvic fracture by targeting the terminal sensory articular nerve branches of the femoral nerve (FN), obturator nerve (ON), and accessory obturator nerve (AON). At this time there has been no study comparing the efficacy of the two nerve blocks, PENG and FIC.\n\nThis aim of this study is to compare the efficacy of the PENG block (20mL of Bupivacaine 0.50%) to that of the FIC block (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED. Our hypothesis is that PENG will demonstrate analgesia that is non-inferior to FIC. Subjective pain scores on a scale of 0 to 10 will be assessed before and after the block. All subjects will receive 4mg of morphine after consent and prior to the block.\n\nA secondary aim is to show that the PENG block is preferable to the FIC block because it does not target motor nerves, thus preserving motor function allowing for an accurate neurological exam and hopefully providing for earlier ambulation. Also, we aim to determine if PENG block results in an significant reduction in amount of systemic pain medication needed for the patient.\n\nThis is a single-centered, prospective, randomized, blinded study involving patients who present to the ED with an isolated hip fracture. Patients who meet inclusion criteria will be consented for the study and then randomized to receive either a FIC block or a PENG block. Patients who are potentially to be enrolled in the study will receive standardized systemic analgesia while awaiting x-rays. If needed, patients will be administered morphine for breakthrough pain after the nerve blocks are placed. The exception to this standardization will be patients with a morphine allergy.\n\nThe research associate will screen for patients and confirm with the attending physician that the subject is eligible for enrollment and is able to give consent. The patient consented by a member of the research team, who will assess the patient's pain score on a scale of 0 to 10 prior to the block. The patient will then be randomized to receive either the FIC block or the PENG block to be performed by a member of the ultrasound faculty. The research associate will be blinded to the type of block being performed by the ultrasound faculty member. The research associate will then reassess the patient's pain score on the 0-10 scale at the 30 minute and 60-minute mark. They will also assess for any adverse events after the block is performed. The research associate will note the motor function in the quadriceps muscle 30 min and 60 min after the nerve block is placed. Any rescue medication given after the nerve block is placed in the ED will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Emergency Medicine Patients over 18 years of age\n* Isolated hip fracture, intertrocanteric or more proximal\n* Pain score 5 or greater on a scale of 0 to 10 just prior to nerve block placement\n\nExclusion Criteria:\n\n* Patients with multi-system trauma\n* People who are unable to communicate their level of pain\\\\\n* Pregnant patients\n* Pediatric Patients (less than 18 years of age)\n* Intoxicated Patients\n* Abnormal Vital Signs (HR\\>120bpm, MAP \\<65, Pulse Ox \\<95%)\n* Patients on long term systemic opioid analgesia\n* Allergy to amide local anesthetics'}, 'identificationModule': {'nctId': 'NCT05102760', 'briefTitle': 'PENG vs. FIC Block for Hip Fracture ED Patients', 'organization': {'class': 'OTHER', 'fullName': 'Maimonides Medical Center'}, 'officialTitle': 'Pericapsular Nerve Group (PENG) Block vs. the Fascia Iliaca Compartment (FIC) Block for Patients With Isolated Hip Fractures in the Emergency Department', 'orgStudyIdInfo': {'id': '2021-02-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fascia Iliaca Compartment', 'description': 'Fascial Iliaca block (FIC) (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED', 'interventionNames': ['Procedure: Nerve Block using FIC Proceedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PENG Block', 'description': 'Pericapsular Nerve Group (PENG) Block (20mL of Bupivacaine 0.50%)', 'interventionNames': ['Procedure: Nerve Block using PENG Proceedure']}], 'interventions': [{'name': 'Nerve Block using FIC Proceedure', 'type': 'PROCEDURE', 'description': 'Ultrasound Guided Nerve Block for Hip Fracture Patients using the FIC Proceedure', 'armGroupLabels': ['Fascia Iliaca Compartment']}, {'name': 'Nerve Block using PENG Proceedure', 'type': 'PROCEDURE', 'description': 'Ultrasound Guided Nerve Block for Hip Fractures Patients using the PENG Procedure', 'armGroupLabels': ['PENG Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11209', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Lawrence Haines, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maimonides Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antonios Likourezos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Administration Director', 'investigatorFullName': 'Antonios Likourezos', 'investigatorAffiliation': 'Maimonides Medical Center'}}}}