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
Busl K, Smith C, Troxel A, Fava M, Illenberger N, Pop R, Yang W, Frota L, Gao H, Shan G, Hoh B, Maciel C. 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. Neurocritical Care 2024, 1-11. PMID: 39138719, DOI: 10.1007/s12028-024-02078-z.Peer-Reviewed Original ResearchSequential parallel comparison designDouble-blindPain controlPterygopalatine fossaClinical trialsPlacebo-Controlled Clinical TrialPrimary tolerability end pointEnd pointsVerbal pain scoresEfficacy end pointOpen-label phaseTolerability end pointsPhase III trialsPost-subarachnoid hemorrhagePhase IIIII trialsPain scoresAcute headacheAneurysmal SAHSevere headachePeriprocedural monitoringPost-SAHHeadache phenotypeUltrasound guidanceAwake patients