RecruitingPhase 2NCT06008795

BLOCK-SAH - PPF-Block for Post-SAH Headache

Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage


Sponsor

University of Florida

Enrollment

195 participants

Start Date

Dec 17, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Placebo Pteryogpalatine Fossa Injection and a drug called Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone for people with headache and subarachnoid hemorrhage, aneurysmal. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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(13)

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Cleveland Clinic Foundation Martin Health

Stuart, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Maryland Baltimore

Baltimore, Maryland, United States

Creighton University Medical Center

Omaha, Nebraska, United States

University of Rochester Medical College

Rochester, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Oregon Health and Sciences University

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Washington

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06008795


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