Health Trials

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 groups

Locations

11
Florida
University of Florida32610, Gainesville United States
Georgia
Emory University30322, Atlanta United States
Maryland
University of Maryland Baltimore21201, Baltimore United States
Minnesota
Mayo Clinic55009, Rochester United States

Sponsors 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