Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage
University of Florida
Summary
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
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated ICF by participant or a legally authorized representative (LAR) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged ≥18 and ≤ 85 years 4. Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hours of ictus hemorrhage 5. Disease-specific inclusion criteria: 1. Spontaneous, non-traumatic SAH 2. Subarachnoid pattern of hemorrhage warranting diagnos…
Interventions
- DrugPterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
- ProcedurePlacebo Pteryogpalatine Fossa Injection
Each placebo PPF-injection will consist of 5ml normal saline
Locations (11)
- University of FloridaGainesville, Florida
- Emory UniversityAtlanta, Georgia
- University of Maryland BaltimoreBaltimore, Maryland
- Mayo ClinicRochester, Minnesota
- Albany Medical CollegeAlbany, New York
- University of Rochester Medical CollegeRochester, New York