RecruitingSubarachnoid Hemorrhage, AneurysmalHeadache

BLOCK-SAH - PPF-Block for Post-SAH Headache

Eligible age

18–85 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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)

Sponsor: University of Florida

You may not qualify if…

✕ An individual who meets any of the following criteria will be excluded from participation in this study:
✕ 1. Premorbid conditions:
✕ 1. 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
✕ 2. Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)
✕ 3. Prior use of opioid or barbiturate analgesics for at least two-thirds of the days in previous month, regardless of indication
✕ 4. Diagnosis of substance use disorder in the previous year
✕ 5. Infected or wounded skin, or a skin lesion at the site of puncture for PPF- injection
✕ 2. Uncorrected coagulopathy