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RECRUITING
NCT06008795
PHASE2

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

Sponsor: University of Florida

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

195

Start Date

2023-12-17

Completion Date

2027-02-28

Last Updated

2025-11-28

Healthy Volunteers

No

Interventions

DRUG

Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone

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

PROCEDURE

Placebo Pteryogpalatine Fossa Injection

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

Locations (11)

University of Florida

Gainesville, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Maryland Baltimore

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

Albany Medical College

Albany, New York, United States

University of Rochester Medical College

Rochester, New York, 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