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

The trial has a primary efficacy end point (oral morphine equivalent/day use within 24 h after each PPF-injection), a primary safety end point (incidence of radiographic vasospasm at 48 h from first PPF-injection), and a primary tolerability end point (rate of acceptance of second PPF-injection following the first PPF-injection). BLOCK-SAH will inform the design of a phase III trial to establish the efficacy of PPF-block, accounting for different headache phenotypes.

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Publication Details

Journal
Neurocritical Care
Published
2024-08-13
DOI
https://doi.org/10.1007/s12028-024-02078-z
Citations
7
Primary Topic
Intracranial Aneurysms: Treatment and Complications
Type
article
Field-Weighted Citation Impact
2.58

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article

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

Nohra El Chalouhi, Omar Dyara, John P. Bruno, Ferenc Rabai et al.
7 citations
Neurocritical Care
Intracranial Aneurysms: Treatment and Complications
2.58
article

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

Nohra El Chalouhi, Omar Dyara, John P. Bruno, Ferenc Rabai, Andrea B. Troxel, Gwynne Kirchen, Katharina M. Busl, Clifton Houk, Sebastián Gatica-Moris, W. Christopher Fox, Matthew T. Bender, Joseph M. Miller, Vladimir Suric, Andrey Suprun, K. C. Brennan, Wenqing Yang, Mark Williams, Olga C. Nin, Oscar Jim Michael Coppes, Matthew J. Koch, Ines P. Koerner, Thomas Mattingly, Narayan Kissoon, Yawar J. Qadri, Angela De Luca, Jacob Labinski, Brandon Peter Lucke-Wold, Kathryn Rosenblatt, Tarun Bhalla, Connie Chung, Panayiotis N. Varelas, Do Hoon Lim, Charles E. Argoff, Ofer Sadan, Owen Samuels, Soleil S. Schutte, Erin F. Barnes, Stavropoula I. Tjoumakaris, James P. Rathmell, Thiago Carneiro, Alejandro A. Rabinstein, Pouya Ameli, Amy Gunnett, Chyann Moore, Shilpa Haldal, Peter Reuter, Muhib Khan, Michael Levitt, Andras Laufer, Michele Curatolo, Elird Bojaxhi, Carey Huebert, Cameron Smith, Sindhuja Nimma, Sarah Wahlster, Yury Zasimovich, Adam Crisologo, Kimberly Mauer, Matthew J. Pingree, Robert Randolph Edwards, Brian Lim Hoh, Robert H. Rosenwasser, Sarah Endrizzi, Gregory Rozansky, Svetlana Chembrovich, Abhijit V. Lele, Nibras Bughrara, Ralisa Pop, Isaac Luria, Pascal M. Jabbour, Jaime L. Baratta, Jeffrey B. Peel, Nabeel Herial, Bakhtawar Ahmad, Christine Spainhour, Kinga Aitken, Lauren Ng, S Soler, Ewa Szymkiewicz, Richa Wardhan, Tommy Thomas, Michael Reid Gooch, Guogen Shan, Jennifer Hernandez-Meier, Christopher Kramer, Héctor David Meza Comparán, Amy Headlee, Carolina B. Maciel, Nabeel Chauhan, Tom P. Aufderheide, Bridget Neja, Maurizio Fava, Patrick Tighe, William D. Freeman, Anna Curtis, Sarah Feller, Barys Ihnatsenka, Linda Le-Wendling, Nicholas Nelson, Antonia Heininger, Daniela Pomar-Forero, Anum Khaliq, Luciola Martins Frota, Magali Jorand‐Fletcher, Jane L. Sultze, Wendell Gaskins, James Lee, Ali Mustafa, Ivan Da Silva, Michael A. Pizzi, Juan Acosta, Martina Flynn, Nadirah Jones, Christopher P. Robinson, Melissa Johnson, Michael Stanley, Christopher Figueroa, José Ignacio Suárez, Nicholas Illenberger, Joshua Wais, Kevin Priddy, Laura Glicksman, Matthew Mallard, Tilor Hallquist, Charlie Biluck, John Roberge, Justin Roberge, Zoe Belge, Yurerkis Montas, Amber Patchell, Miriam Anacker, Ali Daha, James LaTourette, Linda Mattrisch, Elena Spontak, Devin Gillespie, C. M. Hendricks, Mercedes Helm, Alan S. Boulos, Hanzhi Gao, Federico Jimenez Ruiz, Mahtab Sheikh, Ethan R. Schlecht, Amanda Dyer, Beulah Augustin, B.S. Crawford, Adrienne James, Eusebia Calvillo, Carissa Lin, Jamie Jasti, Sarah B. Abdallah, Toni Schaeffer, Pablo Valdes Barrera, Megan Gauthier, Kelsey Dalton, Derek George, Daniia Newman, Tina Tuong-Vi Le Doshi, Imad Khan
article en
7 citations

Abstract

The trial has a primary efficacy end point (oral morphine equivalent/day use within 24 h after each PPF-injection), a primary safety end point (incidence of radiographic vasospasm at 48 h from first PPF-injection), and a primary tolerability end point (rate of acceptance of second PPF-injection following the first PPF-injection). BLOCK-SAH will inform the design of a phase III trial to establish the efficacy of PPF-block, accounting for different headache phenotypes.

Neurocritical CareVol. 42(1)
Boston University (US), Mayo Clinic (US), Johns Hopkins University (US), Thomas Jefferson University (US), Emory University (US), Oregon Health & Science University (US), University of Washington (US), Medical College of Wisconsin (US), University of Utah (US), Jacksonville College (US), University of Rochester Medical Center (US), University of Florida (US), Massachusetts General Hospital (US), Mayo Clinic in Florida (US), New York University (US), Seattle University (US), Albany Medical Center Hospital (US), Florida College (US)
Emory University, Johns Hopkins University, National Institute of Neurological Disorders and Stroke
No poverty
Openalex Percentile: Top 10%
Intracranial Aneurysms: Treatment and Complications
2.58
DOIOpen Access PDFOpenAlex
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