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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
195
Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
Each placebo PPF-injection will consist of 5ml normal saline
University of Florida
Gainesville, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGPrimary Efficacy Endpoint
prn oral morphine equivalent (OME)/day use
Time frame: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period
Primary Safety Endpoint
incidence of radiographic vasospasm
Time frame: at 48 hours from first PPF-injection (end of double-blinded treatment period)
Primary Tolerability Endpoint
rate of acceptance of second PPF-injection
Time frame: at 24 hours following the first PPF-injection
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University of Maryland Baltimore
Baltimore, Maryland, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGAlbany Medical College
Albany, New York, United States
RECRUITINGUniversity of Rochester Medical College
Rochester, New York, United States
RECRUITINGUniversity of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGOregon Health and Sciences University
Portland, Oregon, United States
RECRUITINGThomas Jefferson University
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGUniversity of Washington
Seattle, Washington, United States
RECRUITING...and 1 more locations