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BLOCK-SAH - PPF-Block for Post-SAH Headache

Study acronym: BLOCK-SAH
StatusRecruiting
PhasePhase 2
Started2023-12-17
View on ClinicalTrials.gov ↗

Amendment history

2026-07-01
Study Status, Contacts/Locations v7
Study sites11→13
2025-11-25
Study Status, Contacts/Locations v6
Study sites12→11
2025-05-27
Study Identification, Study Status, Eligibility v5
Eligibility criteria+47 characters
Inclusion Criteria: In order to be eligible to participate in this study, an ind [...] of the following criteria: Provision of signed and dated ICF by participant or a legally authorized representative (LAR) Stated willingness to comply with all study procedures and [...] primary diagnosis of spontaneous, non-traumatic, SAH within 4872 hours of ictus hemorrhage Disease-specific inclusion criter [...] essfully treat culprit vascular lesion Diffuse vasospasm on initialpre-enrollment diagnostic CTA or DSA. Vasospasm is defined as moderate-to- [...]
2025-05-12
Study Status, Eligibility v4
Eligibility criteria+260 characters
[...] rs of ictus hemorrhage Disease-specific inclusion criteria: AneurysmSpontaneous, identifiednon-traumatic asSAH Subarachnoid culpritpattern of SAHhemorrhage 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 modifiedModified Fisher grade 1-4 (on admissionpresentation imaging) Hunt and Hess 1-3 or World Federation of Neurosurg [...] y if also fulfilling Glasgow Coma Scale verbal subscore ≥4) minimumMinimum Glasgow Coma Scale verbal subscore of 4 (on sc [...] [...]
2024-12-23
Study Status, Eligibility, Contacts/Locations v3
Study sites2→12
Eligibility criteria-98 characters
[...] ll of the following criteria: Provision of signed and dated informed consent formICF Stated willingness to comply with all study procedures and [...] ted with a primary diagnosis of spontaneous, non-traumatic, subarachnoid hemorrhageSAH within 48 hours of ictus hemorrhage Disease-specific inclusion criteria: Aneurysm identified as culprit of SAH Modifiedmodified Fisher grade 1-4 (on admission imaging) Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on admissionscreening, included only if also fulfilling Glasgow Coma Scale verbal subscore ≥4) Minimumminimum Glasgow Coma Scale verbal [...] [...]
Show 2 earlier versions
2024-02-28
Study Identification, Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v2
Primary completion date2026-11-30→2027-01-15
Start date2023-11-27→2023-12-17
Study sites1→2
Eligibility criteria+400 characters
[...] c inclusion criteria: Aneurysm identified as culprit of SAH modifiedModified Fisher grade 1-4 (on admission imaging) Hunt and Hess 1-3 o [...] ly if also fulfilling Glasgow Coma Scale verbal subscore≥4) minimumMinimum Glasgow Coma Scale verbal subscore of 4 (on screening) Able [...] of the additional criteria: Stabilization period criteria: BetweenA minimum of 4-48 hours from clipping or coiling procedure (whichever applica [...] literation of aneurysm) Requiring a minimum of 15mg OME prn for headache analgesia during theany 24-hour period immediatelyduring prioreligibility to enrollmentperiod Exclusion Criteria: [...] [...]
Collaborators2 to 3 entries
National Institute of Neurological Disorders and Stroke (NINDS)
2023-11-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-10-15→confirmed 2023-11-27
Study sites0→1
2023-08-18
Original filing
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)
Trial Details
NCT Number NCT06008795
Lead Sponsor University of Florida
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), New York University, Massachusetts General Hospital
Conditions Subarachnoid Hemorrhage, Aneurysmal, Headache
Enrollment 195 participants
Start Date 2023-12-17
Primary Completion 2027-01-15 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-06