NCT06008795 · University of Florida
BLOCK-SAH - PPF-Block for Post-SAH Headache
(BLOCK-SAH)
What this study is about
BLOCK-SAH is a phase II, conducted at multiple hospitals, randomly assigned, double-blinded, compared against an inactive treatment 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-inje
View original scientific description
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-inje
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
Primary outcome measures
Primary Efficacy Endpoint
Time frame: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period
prn oral morphine equivalent (OME)/day use
Primary Safety Endpoint
Time frame: at 48 hours from first PPF-injection (end of double-blinded treatment period)
incidence of radiographic vasospasm
Primary Tolerability Endpoint
Time frame: at 24 hours following the first PPF-injection
rate of acceptance of second PPF-injection
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Spontaneous, non-traumatic SAH 2. Subarachnoid pattern of hemorrhage warranting diagnostic DSA due to involvement of at least one of the following regions: quadrigeminal plate, prepontine cistern, perimesencephalic cistern, Sylvian fissure, or surrounding Circle of Willis 3. Modified Fisher grade 1-4 (on presentation imaging) 4. Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on screening, included only if also fulfilling Glasgow Coma Scale verbal subscore ≥4
Where
- Gainesville, Florida
- Miami, Florida
- Stuart, Florida
- Atlanta, Georgia
- Baltimore, Maryland
- Omaha, Nebraska
- Rochester, New York
- Chapel Hill, North Carolina
- Cincinnati, Ohio
- Portland, Oregon
- Philadelphia, Pennsylvania
- Seattle, Washington
And 1 more location — see the full list below.
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), New York University, Massachusetts General Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations