Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-30 @ 5:33 PM
Study NCT ID:
NCT06008795
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2023-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BLOCK-SAH - PPF-Block for Post-SAH Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential Parallel Comparison Design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 195}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy Endpoint', 'timeFrame': 'within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period', 'description': 'prn oral morphine equivalent (OME)/day use'}, {'measure': 'Primary Safety Endpoint', 'timeFrame': 'at 48 hours from first PPF-injection (end of double-blinded treatment period)', 'description': 'incidence of radiographic vasospasm'}, {'measure': 'Primary Tolerability Endpoint', 'timeFrame': 'at 24 hours following the first PPF-injection', 'description': 'rate of acceptance of second PPF-injection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pterygopalatine Fossa Nerve Block'], 'conditions': ['Subarachnoid Hemorrhage, Aneurysmal', 'Headache']}, 'referencesModule': {'references': [{'pmid': '39138719', 'type': 'DERIVED', 'citation': 'Busl KM, Smith CR, Troxel AB, Fava M, Illenberger N, Pop R, Yang W, Frota LM, Gao H, Shan G, Hoh BL, Maciel CB; BLOCK-SAH Investigators. Rationale and Design for the BLOCK-SAH Study (Pterygopalatine Fossa Block as an Opioid-Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage): A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial with a Sequential Parallel Comparison Design. Neurocrit Care. 2025 Feb;42(1):290-300. doi: 10.1007/s12028-024-02078-z. Epub 2024 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'BLOCK-SAH is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial with a sequential parallel comparison design (SPCD) of bilateral pterygopalatine fossa (PPF) injections with 20mg ropivacaine + 4mg dexamethasone (active, PPF-block) compared to saline (placebo) for headache in survivors of aneurysmal subarachnoid hemorrhage (SAH), while monitoring intracranial arterial mean flow velocities with transcranial Doppler (TCD) peri-intervention (intervention = PPF-injections: active or placebo)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated ICF by participant or a legally authorized representative (LAR)\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged ≥18 and ≤ 85 years\n4. Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hours of ictus hemorrhage\n5. Disease-specific inclusion criteria:\n\n 1. Spontaneous, non-traumatic SAH\n 2. Subarachnoid pattern of hemorrhage warranting diagnostic DSA due to involvement of at least one of the following regions: quadrigeminal plate, prepontine cistern, perimesencephalic cistern, Sylvian fissure, or surrounding Circle of Willis\n 3. Modified Fisher grade 1-4 (on presentation imaging)\n 4. Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on screening, included only if also fulfilling Glasgow Coma Scale verbal subscore ≥4)\n 5. Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)\n6. Able to verbalize pain scale scores according to 11-point numeric pain scale\n\n In order to be enrolled and undergo randomization in this study, an individual must meet all of the additional criteria:\n7. Stabilization period criteria:\n\n 1. A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)\n 2. Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable\n8. Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Premorbid conditions:\n\n 1. Pre-existing neurologic, psychiatric, or other condition that would confound neurologic assessment or would make difficult/impossible to accurately assess neurologic and/or functional outcome\n 2. Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)\n 3. Prior use of opioid or barbiturate analgesics for at least two-thirds of the days in previous month, regardless of indication\n 4. Diagnosis of substance use disorder in the previous year\n 5. Infected or wounded skin, or a skin lesion at the site of puncture for PPF- injection\n2. Uncorrected coagulopathy\n\n 1. Platelet count \\< 50,000/μL, International Normalized Ratio (INR) \\> 1.7\n 2. Requiring use of systemic anticoagulation and antiplatelet therapy (except for aspirin monotherapy).\n3. SAH-specific:\n\n 1. Head trauma as etiology of SAH\n 2. Infection as cause for aneurysm or SAH (i.e., mycotic aneurysms)\n 3. Inability to successfully treat culprit vascular lesion\n 4. Diffuse vasospasm on pre-enrollment diagnostic CTA or DSA. Vasospasm is defined as moderate-to-severe arterial narrowing on DSA or CTA not attributable to atherosclerosis, catheter-induced spasm, or vessel hypoplasia, as determined by a neuroradiologist or neurointerventionalist\n4. Standard pain regimen conditions\n\n 1. Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST or ALT \\> 3x upper limit level)\n 2. Chronic liver condition with absolute contra-indication for APAP (even at lower maximum daily doses)\n5. Participation in a concurrent investigational/interventional study (observational studies allowed)\n6. Known to be pregnant, or with a positive pregnancy test\n7. Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (APAP)\n8. Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)\n9. Unable to receive first PPF-injection within 96 hours of ictus hemorrhage'}, 'identificationModule': {'nctId': 'NCT06008795', 'acronym': 'BLOCK-SAH', 'briefTitle': 'BLOCK-SAH - PPF-Block for Post-SAH Headache', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'IRB CED000000829'}, 'secondaryIdInfos': [{'id': '1U01NS124613-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1U01NS124613-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 - Active - Active', 'description': 'Subjects randomized to Group 1 will receive an active PPF nerve block in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase', 'interventionNames': ['Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone']}, {'type': 'OTHER', 'label': 'Group 2 - Placebo - Active', 'description': 'Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase', 'interventionNames': ['Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone', 'Procedure: Placebo Pteryogpalatine Fossa Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3 - Placebo - Placebo', 'description': 'Subjects randomized to Group 3 will receive a placebo PPF-injection in Stage 1 followed by a placebo PPF-injection in Stage 2 of the Double-Blinded Trial Phase', 'interventionNames': ['Procedure: Placebo Pteryogpalatine Fossa Injection']}], 'interventions': [{'name': 'Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone', 'type': 'DRUG', 'otherNames': ['Pterygopalatine Fossa Nerve Block'], 'description': 'Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone', 'armGroupLabels': ['Group 1 - Active - Active', 'Group 2 - Placebo - Active']}, {'name': 'Placebo Pteryogpalatine Fossa Injection', 'type': 'PROCEDURE', 'description': 'Each placebo PPF-injection will consist of 5ml normal saline', 'armGroupLabels': ['Group 2 - Placebo - Active', 'Group 3 - Placebo - Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carolina Maciel, MD MSCR', 'role': 'CONTACT', 'email': 'carolina.maciel@neurology.ufl.edu', 'phone': '352-273-5500'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Spainhour', 'role': 'CONTACT', 'email': 'christine.spainhour@emory.edu', 'phone': '404-727-1558'}, {'name': 'Ofer Sadan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Oriko', 'role': 'CONTACT', 'email': 'doriko@som.umaryland.edu', 'phone': '410-328-7822'}, {'name': 'Nicholas Morris, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Maryland Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55009', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Headlee', 'role': 'CONTACT', 'email': 'headlee.amy@mayo.edu'}, {'name': 'Narayan Kissoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mahtab Sheikh', 'role': 'CONTACT', 'email': 'sheikhm@amc.edu', 'phone': '518-262-5883'}, {'name': 'Charles Argoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tilor Hallquist', 'role': 'CONTACT', 'email': 'Tilor_Hallquist@URMC.Rochester.edu', 'phone': '585-275-3709'}, {'name': 'Matthew Bender, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Rochester Medical College', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexandra Ramirez', 'role': 'CONTACT', 'email': 'ramiream@ucmail.uc.edu', 'phone': '513-558-0101'}, {'name': 'Charles Prestigiacomo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Cincinnati', 'geoPoint': 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'CONTACT', 'email': 'dolim@uw.edu', 'phone': '206-744-9389'}, {'name': 'Sarah Wahlster, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacob Labinski', 'role': 'CONTACT', 'email': 'jlabinski@mcw.edu', 'phone': '414-805-2578'}, {'name': 'Tom Aufderheide, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Yurerkis Montas', 'role': 'CONTACT', 'email': 'ymontas@partners.org', 'phone': '617-866-9758'}, {'name': 'Ralisa Pop', 'role': 'CONTACT', 'email': 'ralisa.pop@neurology.ufl.edu', 'phone': '352-294-5693'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'New York University', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}