Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-11 @ 2:45 PM
Study NCT ID:
NCT03269435
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2017-08-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Greater Occipital Nerve Block Versus Metoclopramide
Sponsor:
Organization:
Raw JSON
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'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'befriedm@montefiore.org', 'phone': '718-920-6626', 'title': 'Benjamin Friedman', 'organization': 'Montefiore'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Greater Occipital Nerve Block', 'description': 'Bilateral greater occipital nerve block with bupivacaine 0.5%\n\n\\+ Normal saline IV\n\nGreater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 16, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide 10mg IV\n\n\\+ Bilateral greater occipital nerve block with normal saline\n\nMetoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 18, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'head numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Various', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '0-10 Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Greater Occipital Nerve Block', 'description': 'Bilateral greater occipital nerve block with bupivacaine 0.5%\n\n\\+ Normal saline IV\n\nGreater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally'}, {'id': 'OG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide 10mg IV\n\n\\+ Bilateral greater occipital nerve block with normal saline\n\nMetoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '5.8'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '6.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one hour', 'description': 'Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Headache Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Greater Occipital Nerve Block', 'description': 'Bilateral greater occipital nerve block with bupivacaine 0.5%\n\n\\+ Normal saline IV\n\nGreater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally'}, {'id': 'OG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide 10mg IV\n\n\\+ Bilateral greater occipital nerve block with normal saline\n\nMetoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': 'Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Headache Freedom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Greater Occipital Nerve Block', 'description': 'Bilateral greater occipital nerve block with bupivacaine 0.5%\n\n\\+ Normal saline IV\n\nGreater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally'}, {'id': 'OG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide 10mg IV\n\n\\+ Bilateral greater occipital nerve block with normal saline\n\nMetoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': 'Headache = none, achieved in emergency department and maintained for 48 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Greater Occipital Nerve Block', 'description': 'Bilateral greater occipital nerve block with bupivacaine 0.5%\n\n\\+ Normal saline IV\n\nGreater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally'}, {'id': 'FG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide 10mg IV\n\n\\+ Bilateral greater occipital nerve block with normal saline\n\nMetoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Greater Occipital Nerve Block', 'description': 'Bilateral greater occipital nerve block with bupivacaine 0.5%\n\n\\+ Normal saline IV\n\nGreater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally'}, {'id': 'BG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide 10mg IV\n\n\\+ Bilateral greater occipital nerve block with normal saline\n\nMetoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '11', 'groupId': 'BG000'}, {'value': '38', 'spread': '11', 'groupId': 'BG001'}, {'value': '39', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline pain intensity', 'classes': [{'title': 'Severe pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Moderate pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-12', 'size': 424557, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-13T03:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double dummy design with IV placebo and placebo nerve block'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2017-08-18', 'resultsFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-25', 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '0-10 Pain Score', 'timeFrame': 'one hour', 'description': 'Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour'}], 'secondaryOutcomes': [{'measure': 'Sustained Headache Relief', 'timeFrame': '48 hours', 'description': 'Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication'}, {'measure': 'Sustained Headache Freedom', 'timeFrame': '48 hours', 'description': 'Headache = none, achieved in emergency department and maintained for 48 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'We are comparing a type of nerve block called greater occipital nerve block versus standard therapy among patients who present to an emergency department for acute migraine. This is a randomized, double-blind, double dummy study. The greater occipital nerve block will be performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'self-described', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEligible patients are adults who present with an acute moderate or severe headache meeting migraine headache criteria, as defined by the International Classification of Headache Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine without Aura (1.5.1) will also be included, provided they have had at least one similar attack previously.\n\nExclusion Criteria:\n\nPatients will be excluded if informed consent cannot be obtained, if there is concern for a secondary cause of headache, if the maximum documented temperature is greater than 100.3 degrees, for a new objective neurologic abnormality, skull defect, suspected infection overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins, warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior treatment with a greater occipital nerve block, allergy to the investigational medications, pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications."}, 'identificationModule': {'nctId': 'NCT03269435', 'briefTitle': 'Greater Occipital Nerve Block Versus Metoclopramide', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'A Randomized Trial of Greater Occipital Nerve Block With Bupivacaine Versus Intravenous Metoclopramide for Acute Migraine', 'orgStudyIdInfo': {'id': '2017-8249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Greater Occipital Nerve Block', 'description': 'Bilateral greater occipital nerve block with bupivacaine 0.5%\n\n\\+ Normal saline IV', 'interventionNames': ['Procedure: Greater occipital nerve block with bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metoclopramide', 'description': 'Metoclopramide 10mg IV\n\n\\+ Bilateral greater occipital nerve block with normal saline', 'interventionNames': ['Drug: Metoclopramide']}], 'interventions': [{'name': 'Greater occipital nerve block with bupivacaine', 'type': 'PROCEDURE', 'description': 'This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally', 'armGroupLabels': ['Greater Occipital Nerve Block']}, {'name': 'Metoclopramide', 'type': 'DRUG', 'description': 'Metoclopramide 10mg IV will be administered over 15 minutes', 'armGroupLabels': ['Metoclopramide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Benjamin W. Friedman, MD', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}