[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516766":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":38,"locations":48,"responsibleParty":235,"collaborators":237,"id":245,"slug":37,"hasResults":246,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":246,"sex":252,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":37,"studyType":258,"phases":259,"briefSummary":261,"conditions":262,"keywords":265,"overallStatus":50,"whyStopped":37,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Active - Active","ACTIVE_COMPARATOR","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",[13],"Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone",{"label":15,"type":6,"description":16,"interventionNames":17},"Group 2 - Placebo - Active","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",[13,18],"Procedure: Placebo Pteryogpalatine Fossa Injection",{"label":20,"type":21,"description":22,"interventionNames":23},"Group 3 - Placebo - Placebo","PLACEBO_COMPARATOR","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",[18],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone","Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone",[9,15],[31],"Pterygopalatine Fossa Nerve Block",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","Placebo Pteryogpalatine Fossa Injection","Each placebo PPF-injection will consist of 5ml normal saline",[15,20],null,[39,44],{"name":40,"role":41,"phone":42,"phoneExt":37,"email":43},"Yurerkis Montas","CONTACT","617-866-9758","ymontas@partners.org",{"name":45,"role":41,"phone":46,"phoneExt":37,"email":47},"Ralisa Pop","352-294-5693","ralisa.pop@neurology.ufl.edu",[49,66,84,101,117,134,149,166,183,201,218],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Gainesville","Florida","32610","United States",{"type":56,"coordinates":57},"Point",[58,59],-82.32483,29.65163,{"lat":59,"lon":58},[62],{"name":63,"role":41,"phone":64,"phoneExt":37,"email":65},"Carolina Maciel, MD MSCR","352-273-5500","carolina.maciel@neurology.ufl.edu",{"facility":67,"status":50,"city":68,"state":69,"zip":70,"country":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Emory University","Atlanta","Georgia","30322",{"type":56,"coordinates":72},[73,74],-84.38798,33.749,{"lat":74,"lon":73},[77,81],{"name":78,"role":41,"phone":79,"phoneExt":37,"email":80},"Christine Spainhour","404-727-1558","christine.spainhour@emory.edu",{"name":82,"role":83,"phone":37,"phoneExt":37,"email":37},"Ofer Sadan, MD","PRINCIPAL_INVESTIGATOR",{"facility":85,"status":50,"city":86,"state":87,"zip":88,"country":54,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"University of Maryland Baltimore","Baltimore","Maryland","21201",{"type":56,"coordinates":90},[91,92],-76.61219,39.29038,{"lat":92,"lon":91},[95,99],{"name":96,"role":41,"phone":97,"phoneExt":37,"email":98},"David Oriko","410-328-7822","doriko@som.umaryland.edu",{"name":100,"role":83,"phone":37,"phoneExt":37,"email":37},"Nicholas Morris, MD",{"facility":102,"status":50,"city":103,"state":104,"zip":105,"country":54,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Mayo Clinic","Rochester","Minnesota","55009",{"type":56,"coordinates":107},[108,109],-92.4699,44.02163,{"lat":109,"lon":108},[112,115],{"name":113,"role":41,"phone":37,"phoneExt":37,"email":114},"Amy Headlee","headlee.amy@mayo.edu",{"name":116,"role":83,"phone":37,"phoneExt":37,"email":37},"Narayan Kissoon, MD",{"facility":118,"status":50,"city":119,"state":120,"zip":121,"country":54,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Albany Medical College","Albany","New York","12208",{"type":56,"coordinates":123},[124,125],-73.75623,42.65258,{"lat":125,"lon":124},[128,132],{"name":129,"role":41,"phone":130,"phoneExt":37,"email":131},"Mahtab Sheikh","518-262-5883","sheikhm@amc.edu",{"name":133,"role":83,"phone":37,"phoneExt":37,"email":37},"Charles Argoff, MD",{"facility":135,"status":50,"city":103,"state":120,"zip":136,"country":54,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"University of Rochester Medical College","14642",{"type":56,"coordinates":138},[139,140],-77.61556,43.15478,{"lat":140,"lon":139},[143,147],{"name":144,"role":41,"phone":145,"phoneExt":37,"email":146},"Tilor Hallquist","585-275-3709","Tilor_Hallquist@URMC.Rochester.edu",{"name":148,"role":83,"phone":37,"phoneExt":37,"email":37},"Matthew Bender, MD",{"facility":150,"status":50,"city":151,"state":152,"zip":153,"country":54,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":56,"coordinates":155},[156,157],-84.51439,39.12711,{"lat":157,"lon":156},[160,164],{"name":161,"role":41,"phone":162,"phoneExt":37,"email":163},"Alexandra Ramirez","513-558-0101","ramiream@ucmail.uc.edu",{"name":165,"role":83,"phone":37,"phoneExt":37,"email":37},"Charles Prestigiacomo, MD",{"facility":167,"status":50,"city":168,"state":169,"zip":170,"country":54,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Oregon Health and Sciences University","Portland","Oregon","97239",{"type":56,"coordinates":172},[173,174],-122.67621,45.52345,{"lat":174,"lon":173},[177,181],{"name":178,"role":41,"phone":179,"phoneExt":37,"email":180},"Sarah Feller","503-494-6233","fellersa@ohsu.edu",{"name":182,"role":83,"phone":37,"phoneExt":37,"email":37},"Ines Koerner, MD",{"facility":184,"status":185,"city":186,"state":187,"zip":188,"country":54,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Thomas Jefferson University","NOT_YET_RECRUITING","Philadelphia","Pennsylvania","19107",{"type":56,"coordinates":190},[191,192],-75.16362,39.95238,{"lat":192,"lon":191},[195,199],{"name":196,"role":41,"phone":197,"phoneExt":37,"email":198},"Danna Smith","215-955-2173","danna.smith@jefferson.edu",{"name":200,"role":83,"phone":37,"phoneExt":37,"email":37},"Stavropoula Tjoumakaris, MD",{"facility":202,"status":50,"city":203,"state":204,"zip":205,"country":54,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"University of Washington","Seattle","Washington","98104",{"type":56,"coordinates":207},[208,209],-122.33207,47.60621,{"lat":209,"lon":208},[212,216],{"name":213,"role":41,"phone":214,"phoneExt":37,"email":215},"Do Lim","206-744-9389","dolim@uw.edu",{"name":217,"role":83,"phone":37,"phoneExt":37,"email":37},"Sarah Wahlster, MD",{"facility":219,"status":50,"city":220,"state":221,"zip":222,"country":54,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":56,"coordinates":224},[225,226],-87.90647,43.0389,{"lat":226,"lon":225},[229,233],{"name":230,"role":41,"phone":231,"phoneExt":37,"email":232},"Jacob Labinski","414-805-2578","jlabinski@mcw.edu",{"name":234,"role":83,"phone":37,"phoneExt":37,"email":37},"Tom Aufderheide, MD",{"type":236,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[238,241,243],{"name":239,"class":240},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":242,"class":6},"New York University",{"name":244,"class":6},"Massachusetts General Hospital","100516766",false,"NCT06008795","BLOCK-SAH - PPF-Block for Post-SAH Headache","Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage","BLOCK-SAH","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\u002Fimpossible to accurately assess neurologic and\u002For 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 \\\u003C 50,000\u002FμL, 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\u002Finterventional 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","ALL","18 Years","85 Years",{"count":256,"type":257},195,"ESTIMATED","INTERVENTIONAL",[260],"PHASE2","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)",[263,264],"Subarachnoid Hemorrhage, Aneurysmal","Headache",[31],"2025-11-25",{"date":268,"type":269},"2025-11-28","ACTUAL",{"date":271,"type":269},"2023-12-17",{"date":273,"type":257},"2027-02-28",{"name":5,"class":6},11]