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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Subarachnoid Hemorrhage, Aneurysmal, Headache

In brief

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)

Key facts

Study ID

NCT06008795

Run by

University of Florida

People needed

195

Starts

2023-12-17

Expected to finish

2027-02-28

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Premorbid conditions:
• Pre-existing neurologic, psychiatric, or other condition that would confound neurologic assessment or would make difficult/impossible to accurately assess neurologic and/or functional outcome
• Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)
• Prior use of opioid or barbiturate analgesics for at least two-thirds of the days in previous month, regardless of indication
• Diagnosis of substance use disorder in the previous year
• Infected or wounded skin, or a skin lesion at the site of puncture for PPF- injection
• Uncorrected coagulopathy
• Platelet count < 50,000/μL, International Normalized Ratio (INR) > 1.7
• Requiring use of systemic anticoagulation and antiplatelet therapy (except for aspirin monotherapy).
• SAH-specific:
• Head trauma as etiology of SAH
• Infection as cause for aneurysm or SAH (i.e., mycotic aneurysms)
• Inability to successfully treat culprit vascular lesion
• Diffuse vasospasm on pre-enrollment diagnostic CTA or DSA. Vasospasm is defined as moderate-to-severe arterial narrowing on DSA or CTA not attributable to atherosclerosis, catheter-induced spasm, or vessel hypoplasia, as determined by a neuroradiologist or neurointerventionalist
• Standard pain regimen conditions
• Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST or ALT > 3x upper limit level)
• Chronic liver condition with absolute contra-indication for APAP (even at lower maximum daily doses)
• Participation in a concurrent investigational/interventional study (observational studies allowed)
• Known to be pregnant, or with a positive pregnancy test
• Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (APAP)
• Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
• Unable to receive first PPF-injection within 96 hours of ictus hemorrhage

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Cleveland Clinic Foundation Martin Health — Stuart, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• University of Maryland Baltimore — Baltimore, Maryland, United States (enrolling)
• Creighton University Medical Center — Omaha, Nebraska, United States (enrolling)
• University of Rochester Medical College — Rochester, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• Oregon Health and Sciences University — Portland, Oregon, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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