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

Background Acute post-subarachnoid hemorrhage (SAH) headaches are common and severe. Management strategies for post-SAH headaches are limited, with heavy reliance on opioids, and pain control is overall poor. Pterygopalatine fossa (PPF) nerve blocks have shown promising results in treatment of acute...

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Published in:Neurocritical care Vol. 42; no. 1; pp. 290 - 300
Main Authors: Busl, Katharina M., Smith, Cameron R., Troxel, Andrea B., Fava, Maurizio, Illenberger, Nicholas, Pop, Ralisa, Yang, Wenqing, Frota, Luciola Martins, Gao, Hanzhi, Shan, Guogen, Hoh, Brian L., Maciel, Carolina B.
Format: Journal Article
Language:English
Published: New York Springer US 01.02.2025
Springer Nature B.V
Subjects:
Adult
Analgesics
Analgesics, Opioid
Anesthetics, Local - administration & dosage
Aneurysms
Clinical trials
Clinical Trials, Phase II as Topic
Critical Care Medicine
Double-Blind Method
Drug use
Female
Headache - drug therapy
Headache - etiology
Headache - therapy
Headaches
Hemorrhage
Hospitalization
Humans
Hypotheses
Intensive
Internal Medicine
Male
Medical imaging
Medicine
Medicine & Public Health
Middle Aged
Morphine
Multicenter Studies as Topic
Narcotics
Nerve Block - methods
Neurology
Neurosurgery
Pain
Pterygopalatine Fossa
Randomized Controlled Trials as Topic
Subarachnoid Hemorrhage - complications
Substance abuse treatment
Take a Closer Look at Trials
Ultrasonic imaging
Headache
Intensive care
Nerve block
Subarachnoid hemorrhage
Opioid analgesics
ISSN:1541-6933, 1556-0961, 1556-0961
Online Access:Get full text
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Summary:Background Acute post-subarachnoid hemorrhage (SAH) headaches are common and severe. Management strategies for post-SAH headaches are limited, with heavy reliance on opioids, and pain control is overall poor. Pterygopalatine fossa (PPF) nerve blocks have shown promising results in treatment of acute headache, including our preliminary and published experience with PPF-blocks for refractory post-SAH headache during hospitalization. The BLOCK-SAH trial was designed to assess the efficacy and safety of bilateral PPF-blocks in awake patients with severe headaches from aneurysmal SAH who require opioids for pain control and are able to verbalize pain scores. Methods BLOCK-SAH is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial using the sequential parallel comparison design (SPCD), followed by an open-label phase. Results Across 12 sites in the United States, 195 eligible study participants will be randomized into three groups to receive bilateral active or placebo PPF-injections for 2 consecutive days with periprocedural monitoring of intracranial arterial mean flow velocities with transcranial Doppler, according to SPCD (group 1: active block followed by placebo; group 2: placebo followed by active block; group 3: placebo followed by placebo). PPF-injections will be delivered under ultrasound guidance and will comprise 5-mL injectates of 20 mg of ropivacaine plus 4 mg of dexamethasone (active PPF-block) or saline solution (placebo PPF-injection). Conclusions 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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ISSN:1541-6933
1556-0961
1556-0961
DOI:10.1007/s12028-024-02078-z