[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516766":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":38,"locations":48,"responsibleParty":236,"collaborators":238,"id":246,"slug":247,"hasResults":248,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":248,"sex":254,"minAge":255,"maxAge":256,"enrollmentInfo":257,"targetDuration":37,"studyType":260,"phases":261,"briefSummary":263,"conditions":264,"keywords":267,"overallStatus":50,"whyStopped":37,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},{"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",[49,67,85,102,118,135,150,167,184,202,219],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Gainesville","Florida","32610","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-82.32483,29.65163,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":65,"phoneExt":37,"email":66},"Carolina Maciel, MD MSCR","352-273-5500","carolina.maciel@neurology.ufl.edu",{"facility":68,"status":50,"city":69,"state":70,"zip":71,"country":54,"countryCode":55,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Emory University","Atlanta","Georgia","30322",{"type":57,"coordinates":73},[74,75],-84.38798,33.749,{"lat":75,"lon":74},[78,82],{"name":79,"role":41,"phone":80,"phoneExt":37,"email":81},"Christine Spainhour","404-727-1558","christine.spainhour@emory.edu",{"name":83,"role":84,"phone":37,"phoneExt":37,"email":37},"Ofer Sadan, MD","PRINCIPAL_INVESTIGATOR",{"facility":86,"status":50,"city":87,"state":88,"zip":89,"country":54,"countryCode":55,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of Maryland Baltimore","Baltimore","Maryland","21201",{"type":57,"coordinates":91},[92,93],-76.61219,39.29038,{"lat":93,"lon":92},[96,100],{"name":97,"role":41,"phone":98,"phoneExt":37,"email":99},"David Oriko","410-328-7822","doriko@som.umaryland.edu",{"name":101,"role":84,"phone":37,"phoneExt":37,"email":37},"Nicholas Morris, MD",{"facility":103,"status":50,"city":104,"state":105,"zip":106,"country":54,"countryCode":55,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Mayo Clinic","Rochester","Minnesota","55009",{"type":57,"coordinates":108},[109,110],-92.4699,44.02163,{"lat":110,"lon":109},[113,116],{"name":114,"role":41,"phone":37,"phoneExt":37,"email":115},"Amy Headlee","headlee.amy@mayo.edu",{"name":117,"role":84,"phone":37,"phoneExt":37,"email":37},"Narayan Kissoon, MD",{"facility":119,"status":50,"city":120,"state":121,"zip":122,"country":54,"countryCode":55,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Albany Medical College","Albany","New York","12208",{"type":57,"coordinates":124},[125,126],-73.75623,42.65258,{"lat":126,"lon":125},[129,133],{"name":130,"role":41,"phone":131,"phoneExt":37,"email":132},"Mahtab Sheikh","518-262-5883","sheikhm@amc.edu",{"name":134,"role":84,"phone":37,"phoneExt":37,"email":37},"Charles Argoff, MD",{"facility":136,"status":50,"city":104,"state":121,"zip":137,"country":54,"countryCode":55,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"University of Rochester Medical College","14642",{"type":57,"coordinates":139},[140,141],-77.61556,43.15478,{"lat":141,"lon":140},[144,148],{"name":145,"role":41,"phone":146,"phoneExt":37,"email":147},"Tilor Hallquist","585-275-3709","Tilor_Hallquist@URMC.Rochester.edu",{"name":149,"role":84,"phone":37,"phoneExt":37,"email":37},"Matthew Bender, MD",{"facility":151,"status":50,"city":152,"state":153,"zip":154,"country":54,"countryCode":55,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":57,"coordinates":156},[157,158],-84.51439,39.12711,{"lat":158,"lon":157},[161,165],{"name":162,"role":41,"phone":163,"phoneExt":37,"email":164},"Alexandra Ramirez","513-558-0101","ramiream@ucmail.uc.edu",{"name":166,"role":84,"phone":37,"phoneExt":37,"email":37},"Charles Prestigiacomo, MD",{"facility":168,"status":50,"city":169,"state":170,"zip":171,"country":54,"countryCode":55,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Oregon Health and Sciences University","Portland","Oregon","97239",{"type":57,"coordinates":173},[174,175],-122.67621,45.52345,{"lat":175,"lon":174},[178,182],{"name":179,"role":41,"phone":180,"phoneExt":37,"email":181},"Sarah Feller","503-494-6233","fellersa@ohsu.edu",{"name":183,"role":84,"phone":37,"phoneExt":37,"email":37},"Ines Koerner, MD",{"facility":185,"status":186,"city":187,"state":188,"zip":189,"country":54,"countryCode":55,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Thomas Jefferson University","NOT_YET_RECRUITING","Philadelphia","Pennsylvania","19107",{"type":57,"coordinates":191},[192,193],-75.16362,39.95238,{"lat":193,"lon":192},[196,200],{"name":197,"role":41,"phone":198,"phoneExt":37,"email":199},"Danna Smith","215-955-2173","danna.smith@jefferson.edu",{"name":201,"role":84,"phone":37,"phoneExt":37,"email":37},"Stavropoula Tjoumakaris, MD",{"facility":203,"status":50,"city":204,"state":205,"zip":206,"country":54,"countryCode":55,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"University of Washington","Seattle","Washington","98104",{"type":57,"coordinates":208},[209,210],-122.33207,47.60621,{"lat":210,"lon":209},[213,217],{"name":214,"role":41,"phone":215,"phoneExt":37,"email":216},"Do Lim","206-744-9389","dolim@uw.edu",{"name":218,"role":84,"phone":37,"phoneExt":37,"email":37},"Sarah Wahlster, MD",{"facility":220,"status":50,"city":221,"state":222,"zip":223,"country":54,"countryCode":55,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":57,"coordinates":225},[226,227],-87.90647,43.0389,{"lat":227,"lon":226},[230,234],{"name":231,"role":41,"phone":232,"phoneExt":37,"email":233},"Jacob Labinski","414-805-2578","jlabinski@mcw.edu",{"name":235,"role":84,"phone":37,"phoneExt":37,"email":37},"Tom Aufderheide, MD",{"type":237,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[239,242,244],{"name":240,"class":241},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":243,"class":6},"New York University",{"name":245,"class":6},"Massachusetts General Hospital","100516766","phase-2-block-sah---ppf-block-for-post-sah-headache-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":258,"type":259},195,"ESTIMATED","INTERVENTIONAL",[262],"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)",[265,266],"Subarachnoid Hemorrhage, Aneurysmal","Headache",[31],"2025-11-25",{"date":270,"type":271},"2025-11-28","ACTUAL",{"date":273,"type":271},"2023-12-17",{"date":275,"type":259},"2027-02-28",{"name":5,"class":6},11]