Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-05 @ 2:40 PM
Study NCT ID:
NCT03909594
Status:
WITHDRAWN
Last Update Posted:
2021-10-11
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bubiket Study: Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-26', 'size': 1179218, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-04T11:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a randomized double blind study - - All the pharmacist and research manager'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The COVID Pandemic delayed start of study and currently the investigators are not interested in conducting the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to first rescue analgesia post-regional nerve blockade', 'timeFrame': '0-24 hours', 'description': 'The difference in time from administration of pain medication to rescue analgesia'}], 'secondaryOutcomes': [{'measure': 'Pain score at 30 minutes', 'timeFrame': '30 minutes', 'description': 'The pain score at 30 minutes at an 11 point Likert Numeric Rating Scale (0 = no pain; 5=moderate pain, and 10 = very severe pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Musculoskeletal']}, 'descriptionModule': {'briefSummary': 'The project is meant to evaluate the effect of a combination of medications (Bupivacaine + Ketamine) used in an ultra-sound guided nerve block for patients presenting to the Emergency Department (ED) with hip and/or femur fractures. The goal is to see whether the combination of these two medications will result in greater and longer-lasting pain relief, longer-lasting motor and sensory block and overall less need for opioid rescue analgesia.', 'detailedDescription': 'STUDY DESIGN\n\nSubjects: Patients aged 18 years and older with isolated hip or femur fracture confirmed on x-ray.\n\nDESIGN:\n\nA randomized double-blind prospective superiority trail.\n\n* Each patient will receive Morphine for analgesia prior to regional nerve block.\n\n * Patients \\< 65 years will receive Morphine 0.1 mg/kg every four hours as needed for 2 doses\n * Patients \\> 65 years will receive Morphine 0.05 mg/kg every four hours as needed for 2 doses\n* Treatment group: will receive an ultrasound guided regional nerve block with Bupivacaine (0.5% or 5 mg/ml) 2.5 mg/kg (max dose 175 kg) + Ketamine (50 mg/ml) 2 mg/kg. Each patient will be given a volume of 40 mL - this will be a mixture of Bupivacaine, Ketamine and 0.9% NS to make up the full 40 ml.\n* Control group: will receive an ultrasound guided regional nerve block with Bupivacaine 0.5% only. Each patient will be given a volume of 40 ml - this will be a mixture of Bupivacaine and 0.9% NS to make up the full volume of 40 mL\n* The patients will be followed with respect to accrual time, follow up time, and total time of the block as well as a need for rescue analgesia as follows: every 15 minutes for the first hour; every 30 minutes for the next hour; every 1 hour for next 4 hours; every 4 hours for next 18 hours with end point of 24 hours or up until they are taken to surgery, whichever comes first.\n* Evaluation of the sensory blocks: will be performed every 5 minutes after administration of the local anesthetic. The sensory block will be quantified as: 0 = Anesthesia (no sensation), 1 = Analgesia (decreased \\[dull\\] sensation), and 2 = no block (normal sensation), by using the pinprick test and comparing with the contralateral limb. The time elapsed from the injection to the onset of analgesia in the central sensory region of femoral nerve block will be taken as time of onset of the sensory block.\n* Rescue Analgesia: If pain is not relieved and the participant requires rescue analgesia a weight-based dose of Morphine will be given at 0.1 mg/kg.\n\nIn addition, an antidote (lipid emulsion) that will be given to patients who need it when they develop severe side effects.\n\nDATA COLLECTION:\n\nPatient demographic, clinical and injury information, pain score, onset of motor and sensory block, rescue analgesia and side effects/adverse events will be collected by using a data collection form by trained research assistant and associates.\n\nDATA ANALYSIS:\n\nStatistical Analyses will include frequency distributions, t-test and chi-square for comparison between and within the groups and Cox Linear Regression Analysis. P\\<.05 will denote statistical significance. Statistical analyses will be conducted via SPSS version 24. Antonios Likourezos or equivalent will perform the statistical analyses.\n\nEXPECTED OUTCOMES:\n\nPRIMARY OUTCOME: time to first rescue analgesia post-regional nerve blockade in each group\n\nSECONDARY OUTCOMES:\n\n• Change in pain score as measured by Visual Analog Scale: Patient to be approached at the following intervals: every 15 minutes for the first hour; every 30 minutes for the next hour; every 1 hour for next 4 hours; every 4 hours for next 18 hours with end point of 24 hours or up until they are taken to surgery, whichever comes first.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Presenting with isolated hip or femur fracture confirmed on x-ray.\n\nExclusion Criteria:\n\n* Polytrauma\n* Unstable vitals signs\n* Allergy to Bupivacaine or Ketamine\n* Inability to give consent\n* Altered mental status\n* Greater than 100kg\n* Known end stage renal disease or hepatic dysfunction\n* Received \\> 2 doses of Morphine in ER prior to regional nerve block\n* Patients with failed nerve block (30 minute onset)'}, 'identificationModule': {'nctId': 'NCT03909594', 'briefTitle': 'Bubiket Study: Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone', 'organization': {'class': 'OTHER', 'fullName': 'Maimonides Medical Center'}, 'officialTitle': 'Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone in Patients With Hip or Femur Fracture: a Double Blind Randomized Clinical Trial (BupiKet)', 'orgStudyIdInfo': {'id': '2018-08-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerve Block with Bupivacaine an', 'description': 'Patients will receive an ultrasound guided regional nerve block with Bupivacaine (0.5% or 5 mg/ml) 2.5 mg/kg (max dose 175 kg) + Ketamine (50 mg/ml) 2 mg/kg. Each patient will be given a volume of 40 mL - this will be a mixture of Bupivacaine, Ketamine and 0.9% NS to make up the full 40 ml.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nerve Block with Bupivacaine al', 'description': 'Patients will receive an ultrasound guided regional nerve block with Bupivacaine 0.5% only. Each patient will be given a volume of 40 ml - this will be a mixture of Bupivacaine and 0.9% NS to make up the full volume of 40 mL', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Bupivacaine', 'armGroupLabels': ['Nerve Block with Bupivacaine al', 'Nerve Block with Bupivacaine an']}, {'name': 'Ketamine', 'type': 'DRUG', 'description': 'Ketamine', 'armGroupLabels': ['Nerve Block with Bupivacaine an']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Sergey Motov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maimonides Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antonios Likourezos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Manager; Co-Investigator', 'investigatorFullName': 'Antonios Likourezos', 'investigatorAffiliation': 'Maimonides Medical Center'}}}}