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Subarachnoid Hemorrhage, AneurysmalPainDrugProcedurePhase 2

What this study is

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)

What's being tested

  • Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone

    Intervention · DRUG

    Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone

  • Placebo Pteryogpalatine Fossa Injection

    Intervention · PROCEDURE

    Each placebo PPF-injection will consist of 5ml normal saline

Study details

Official title
Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage
Sponsor
University of Florida
Conditions
Subarachnoid Hemorrhage, Aneurysmal · Headache
Enrolling
195 people
Starts
2023-12-17
Est. completion
2027-02-28
Design
Quadruple-blind, randomized, sequential groups, Phase 2
Record
View on ClinicalTrials.gov ↗