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)
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. Stabilization period criteria:
✓. A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
Exclusion criteria
✕. Premorbid conditions:
✕. Pre-existing neurologic, psychiatric, or other condition that would confound neurologic assessment or would make difficult/impossible to accurately assess neurologic and/or functional outcome
✕. Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)
✕
What they're measuring
1
Primary Efficacy Endpoint
Timeframe: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period
2
Primary Safety Endpoint
Timeframe: at 48 hours from first PPF-injection (end of double-blinded treatment period)
3
Primary Tolerability Endpoint
Timeframe: at 24 hours following the first PPF-injection