Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02188394
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2014-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthetic Blockades and Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-03', 'studyFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the number of days with moderate/intense migraine', 'timeFrame': 'Baseline (1 week before) and 1 week after intervention', 'description': 'A headache diary will register the number of days with moderate/intense migraine. Moderate/intense migraine is considered a headache with an intensity level over 4 points on a numerical pain rate scale (NPRS, 0-10)'}], 'secondaryOutcomes': [{'measure': 'Changes in the number of days with mild/moderate migraine', 'timeFrame': 'Baseline (1 week before) and 1 week after intervention', 'description': 'A headache diary will register the number of days with mild/moderate migraine. Moderate/intense migraine is considered a headache with an intensity level under 4 points on a numerical pain rate scale (NPRS, 0-10)'}, {'measure': 'Changes in the number of symptomatic medication drugs', 'timeFrame': 'Baseline (1 week before) and 1 week after intervention', 'description': 'The subjects will register in the headache diary the number of days per week in which they need symptomatic medical drugs for relief the headache attack'}, {'measure': 'Changes in pressure pain thresholds', 'timeFrame': 'Baseline, 1 hour after and 1 week after intervention', 'description': 'Pressure pain thresholds will be assessed over the supraorbital, infraorbital and mental nerves, and over the second metacarpal and tibialis anterior muscle'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['migraine,', 'pressure pain,', 'anesthetic blocks', 'patients'], 'conditions': ['Chronic Migraine', 'Pain']}, 'referencesModule': {'references': [{'pmid': '27296456', 'type': 'DERIVED', 'citation': 'Cuadrado ML, Aledo-Serrano A, Navarro P, Lopez-Ruiz P, Fernandez-de-Las-Penas C, Gonzalez-Suarez I, Orviz A, Fernandez-Perez C. Short-term effects of greater occipital nerve blocks in chronic migraine: A double-blind, randomised, placebo-controlled clinical trial. Cephalalgia. 2017 Aug;37(9):864-872. doi: 10.1177/0333102416655159. Epub 2016 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs) in different areas. We hypothesize that those patients receiving real GON anesthetic blockade will receive greater improvements in pain nociception. We will conduct a double-blind, randomized, parallel and placebo-controlled clinical trial where one group will be treated with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic migraine\n\nExclusion Criteria:\n\n* Other primary headaches\n* Other secondary headaches\n* Co-morbid medical diseases'}, 'identificationModule': {'nctId': 'NCT02188394', 'briefTitle': 'Anesthetic Blockades and Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Effects of Anesthetic Blockades on Pain Modulation in Migraine', 'orgStudyIdInfo': {'id': 'HCSC11/263'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anesthetic blockades with bupivacaine', 'description': 'Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5%', 'interventionNames': ['Drug: Anesthetic blockades with bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic saline injection', 'description': 'Patients will receive a bilateral occipital injection with isotonic saline', 'interventionNames': ['Drug: Isotonic saline injection']}], 'interventions': [{'name': 'Anesthetic blockades with bupivacaine', 'type': 'DRUG', 'armGroupLabels': ['Anesthetic blockades with bupivacaine']}, {'name': 'Isotonic saline injection', 'type': 'DRUG', 'armGroupLabels': ['Isotonic saline injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Maria Luz Cuadrado, MD; PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinico San Carlos-Universidad Complutense de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'César Fernández-de-las-Peñas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Proffesor', 'investigatorFullName': 'César Fernández-de-las-Peñas', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}