BLOCK-SAH - PPF-Block for Post-SAH Headache
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Florida
About this trial
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)
Eligibility criteria
Qualifiers
Provision of signed and dated ICF by participant or a legally authorized representative (LAR)
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged ≥18 and ≤ 85 years
Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hours of ictus hemorrhage
Disqualifiers
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)
Prior use of opioid or barbiturate analgesics for at least two-thirds of the days in previous month, regardless of indication
Diagnosis of substance use disorder in the previous year
Trial design
Treatments tested in this trial
- Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
- Placebo Pteryogpalatine Fossa Injection
Treatment groups
195 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Florida
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
New York University
Collaborator
Massachusetts General Hospital
Collaborator
Source ClinicalTrials.gov