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
Department of Neurology, College of Medicine, University of Florida, McKnight Brain Institute, L3-100, 1149 Newell Drive, Gainesville, FL, 32608, USA.
Department of Neurosurgery, College of Medicine, University of Florida, Gainesville, FL, USA.
Neurocrit Care. 2025 Feb;42(1):290-300. doi: 10.1007/s12028-024-02078-z. Epub 2024 Aug 13.
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.
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.
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).
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.
蛛网膜下腔出血（SAH）后急性头痛常见且严重。SAH后头痛的管理策略有限，严重依赖阿片类药物，总体疼痛控制效果不佳。翼腭窝（PPF）神经阻滞在急性头痛治疗中已显示出有前景的结果，包括我们在住院期间对难治性SAH后头痛进行PPF阻滞的初步经验及已发表的相关经验。BLOCK-SAH试验旨在评估双侧PPF阻滞对因动脉瘤性SAH导致严重头痛、需要使用阿片类药物控制疼痛且能够说出疼痛评分的清醒患者的疗效和安全性。
BLOCK-SAH是一项II期、多中心、随机、双盲、安慰剂对照的临床试验，采用序贯平行比较设计（SPCD），随后是开放标签阶段。
在美国的12个地点，195名符合条件的研究参与者将被随机分为三组，根据SPCD连续2天接受双侧活性或安慰剂PPF注射，同时在围手术期用经颅多普勒监测颅内动脉平均流速（第1组：先进行活性阻滞，然后是安慰剂；第2组：先进行安慰剂，然后是活性阻滞；第3组：先进行安慰剂，然后是安慰剂）。PPF注射将在超声引导下进行，注射剂为5毫升含20毫克罗哌卡因加4毫克地塞米松的溶液（活性PPF阻滞）或盐水溶液（安慰剂PPF注射）。
该试验有一个主要疗效终点（每次PPF注射后24小时内口服吗啡等效剂量/天的用量）、一个主要安全终点（首次PPF注射后48小时放射性血管痉挛的发生率）和一个主要耐受性终点（首次PPF注射后接受第二次PPF注射的比例）。BLOCK-SAH将为III期试验的设计提供信息，以确定PPF阻滞的疗效，同时考虑不同的头痛表型。
