Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage
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)
‣ Spontaneous, non-traumatic SAH
⁃ Subarachnoid pattern of hemorrhage 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
⁃ Modified Fisher grade 1-4 (on presentation imaging)
⁃ Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on screening, included only if also fulfilling Glasgow Coma Scale verbal subscore ≥4)
⁃ Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)
• Able to verbalize pain scale scores according to 11-point numeric pain scale
• In order to be enrolled and undergo randomization in this study, an individual must meet all of the additional criteria:
• Stabilization period criteria:
‣ A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
⁃ Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable
• Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period