[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516766":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":38,"locations":48,"responsibleParty":271,"collaborators":273,"id":281,"slug":282,"hasResults":283,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":283,"sex":289,"minAge":290,"maxAge":291,"enrollmentInfo":292,"targetDuration":37,"studyType":295,"phases":296,"briefSummary":298,"conditions":299,"keywords":302,"overallStatus":50,"whyStopped":37,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},{"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",[49,67,84,100,117,134,151,168,185,202,219,237,254],{"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":52,"zip":70,"country":54,"countryCode":55,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"University of Miami","Miami","33136",{"type":57,"coordinates":72},[73,74],-80.19366,25.77427,{"lat":74,"lon":73},[77,81],{"name":78,"role":41,"phone":79,"phoneExt":37,"email":80},"Ana Karen Bolaños","305-243-3063","axb2916@med.miami.edu",{"name":82,"role":83,"phone":37,"phoneExt":37,"email":37},"Nina Massad, MD","PRINCIPAL_INVESTIGATOR",{"facility":85,"status":50,"city":86,"state":52,"zip":87,"country":54,"countryCode":55,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Cleveland Clinic Foundation Martin Health","Stuart","34994",{"type":57,"coordinates":89},[90,91],-80.25283,27.19755,{"lat":91,"lon":90},[94,98],{"name":95,"role":41,"phone":96,"phoneExt":37,"email":97},"Irene Ball","772-763-9317","balli@ccf.org",{"name":99,"role":83,"phone":37,"phoneExt":37,"email":37},"Marc Babi, MD",{"facility":101,"status":50,"city":102,"state":103,"zip":104,"country":54,"countryCode":55,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Emory University","Atlanta","Georgia","30322",{"type":57,"coordinates":106},[107,108],-84.38798,33.749,{"lat":108,"lon":107},[111,115],{"name":112,"role":41,"phone":113,"phoneExt":37,"email":114},"Christine Spainhour","404-727-1558","christine.spainhour@emory.edu",{"name":116,"role":83,"phone":37,"phoneExt":37,"email":37},"Ofer Sadan, MD",{"facility":118,"status":50,"city":119,"state":120,"zip":121,"country":54,"countryCode":55,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"University of Maryland Baltimore","Baltimore","Maryland","21201",{"type":57,"coordinates":123},[124,125],-76.61219,39.29038,{"lat":125,"lon":124},[128,132],{"name":129,"role":41,"phone":130,"phoneExt":37,"email":131},"David Oriko","410-328-7822","doriko@som.umaryland.edu",{"name":133,"role":83,"phone":37,"phoneExt":37,"email":37},"Nicholas Morris, MD",{"facility":135,"status":50,"city":136,"state":137,"zip":138,"country":54,"countryCode":55,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Creighton University Medical Center","Omaha","Nebraska","68124",{"type":57,"coordinates":140},[141,142],-95.94043,41.25626,{"lat":142,"lon":141},[145,149],{"name":146,"role":41,"phone":147,"phoneExt":37,"email":148},"Caroline Nubel","402-280-4032","CarolineNubel@creighton.edu",{"name":150,"role":83,"phone":37,"phoneExt":37,"email":37},"Jason Lambrecht, MD",{"facility":152,"status":50,"city":153,"state":154,"zip":155,"country":54,"countryCode":55,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"University of Rochester Medical College","Rochester","New York","14642",{"type":57,"coordinates":157},[158,159],-77.61556,43.15478,{"lat":159,"lon":158},[162,166],{"name":163,"role":41,"phone":164,"phoneExt":37,"email":165},"Tilor Hallquist","585-275-3709","Tilor_Hallquist@URMC.Rochester.edu",{"name":167,"role":83,"phone":37,"phoneExt":37,"email":37},"Matthew Bender, MD",{"facility":169,"status":50,"city":170,"state":171,"zip":172,"country":54,"countryCode":55,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"University of North Carolina","Chapel Hill","North Carolina","27599",{"type":57,"coordinates":174},[175,176],-79.05584,35.9132,{"lat":176,"lon":175},[179,183],{"name":180,"role":41,"phone":181,"phoneExt":37,"email":182},"Leyla Hatfield","919-445-2620","hatfieldl@neurology.unc.edu",{"name":184,"role":83,"phone":37,"phoneExt":37,"email":37},"Lindsey Krawchuk, MD",{"facility":186,"status":50,"city":187,"state":188,"zip":189,"country":54,"countryCode":55,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":57,"coordinates":191},[192,193],-84.51439,39.12711,{"lat":193,"lon":192},[196,200],{"name":197,"role":41,"phone":198,"phoneExt":37,"email":199},"Alexandra Ramirez","513-558-0101","ramiream@ucmail.uc.edu",{"name":201,"role":83,"phone":37,"phoneExt":37,"email":37},"Charles Prestigiacomo, MD",{"facility":203,"status":50,"city":204,"state":205,"zip":206,"country":54,"countryCode":55,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Oregon Health and Sciences University","Portland","Oregon","97239",{"type":57,"coordinates":208},[209,210],-122.67621,45.52345,{"lat":210,"lon":209},[213,217],{"name":214,"role":41,"phone":215,"phoneExt":37,"email":216},"Sarah Feller","503-494-6233","fellersa@ohsu.edu",{"name":218,"role":83,"phone":37,"phoneExt":37,"email":37},"Ines Koerner, MD",{"facility":220,"status":221,"city":222,"state":223,"zip":224,"country":54,"countryCode":55,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Thomas Jefferson University","NOT_YET_RECRUITING","Philadelphia","Pennsylvania","19107",{"type":57,"coordinates":226},[227,228],-75.16362,39.95238,{"lat":228,"lon":227},[231,235],{"name":232,"role":41,"phone":233,"phoneExt":37,"email":234},"Danna Smith","215-955-2173","danna.smith@jefferson.edu",{"name":236,"role":83,"phone":37,"phoneExt":37,"email":37},"Stavropoula Tjoumakaris, MD",{"facility":238,"status":50,"city":239,"state":240,"zip":241,"country":54,"countryCode":55,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"University of Washington","Seattle","Washington","98104",{"type":57,"coordinates":243},[244,245],-122.33207,47.60621,{"lat":245,"lon":244},[248,252],{"name":249,"role":41,"phone":250,"phoneExt":37,"email":251},"Do Lim","206-744-9389","dolim@uw.edu",{"name":253,"role":83,"phone":37,"phoneExt":37,"email":37},"Sarah Wahlster, MD",{"facility":255,"status":50,"city":256,"state":257,"zip":258,"country":54,"countryCode":55,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":57,"coordinates":260},[261,262],-87.90647,43.0389,{"lat":262,"lon":261},[265,269],{"name":266,"role":41,"phone":267,"phoneExt":37,"email":268},"Jacob Labinski","414-805-2578","jlabinski@mcw.edu",{"name":270,"role":83,"phone":37,"phoneExt":37,"email":37},"Tom Aufderheide, MD",{"type":272,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[274,277,279],{"name":275,"class":276},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":278,"class":6},"New York University",{"name":280,"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":293,"type":294},195,"ESTIMATED","INTERVENTIONAL",[297],"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)",[300,301],"Subarachnoid Hemorrhage, Aneurysmal","Headache",[31],"2026-07-01",{"date":305,"type":306},"2026-07-06","ACTUAL",{"date":308,"type":306},"2023-12-17",{"date":310,"type":294},"2027-02-28",{"name":5,"class":6},13]