Actively Recruiting
BLOCK-SAH - PPF-Block for Post-SAH Headache
Led by University of Florida · Updated on 2025-11-28
195
Participants Needed
11
Research Sites
167 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
BLOCK-SAH - PPF-Block for Post-SAH Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by participant or legally authorized representative
- Willingness to follow all study procedures and be available for the study duration
- Male or female aged 18 to 85 years
- Admitted with spontaneous, non-traumatic subarachnoid hemorrhage within 72 hours of onset
- Subarachnoid hemorrhage pattern requiring diagnostic angiography involving specific brain regions
- Modified Fisher grade between 1 and 4 on imaging
- Hunt and Hess grade 1 to 3 or World Federation of Neurosurgeons grade 1 to 4 with verbal Glasgow Coma Scale subscore of 4 or higher
- Able to verbally rate pain using an 11-point numeric scale
- At least 4 hours have passed since angiography with clipping or coiling if performed
- Successful treatment of the vascular lesion with at least 90% aneurysm obliteration if applicable
- Requires at least 15 mg oral morphine equivalent as needed for headache in any 24-hour period during eligibility
You will not qualify if you...
- Pre-existing neurologic, psychiatric, or other conditions interfering with neurologic or functional assessment
- Pre-existing diffuse arterial narrowing in the Circle of Willis from any cause
- Opioid or barbiturate use for at least two-thirds of the days in the previous month
- Diagnosis of substance use disorder within the past year
- Skin infection, wound, or lesion at injection site
- Platelet count below 50,000/µL or INR above 1.7
- Need for systemic anticoagulation and antiplatelet therapy except aspirin alone
- SAH caused by head trauma or infection (mycotic aneurysms)
- Inability to successfully treat the vascular lesion
- Diffuse vasospasm on diagnostic imaging not caused by atherosclerosis or catheter spasm
- Elevated liver enzymes prohibiting scheduled acetaminophen use
- Chronic liver disease contraindicating acetaminophen
- Participation in other interventional studies (observational studies allowed)
- Known pregnancy or positive pregnancy test
- Allergy or intolerance to ropivacaine, dexamethasone, or acetaminophen
- Vulnerable populations such as prisoners
- Unable to receive first PPF injection within 96 hours of hemorrhage onset
AI-Screening
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Trial Site Locations
Total: 11 locations
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55009
Actively Recruiting
5
Albany Medical College
Albany, New York, United States, 12208
Actively Recruiting
6
University of Rochester Medical College
Rochester, New York, United States, 14642
Actively Recruiting
7
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
8
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
9
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
10
University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
11
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
Y
Yurerkis Montas
CONTACT
R
Ralisa Pop
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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