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

Last updated: May 27, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

2

Condition

Stroke

Pain (Pediatric)

Hemorrhage

Treatment

Placebo Pteryogpalatine Fossa Injection

Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone

Clinical Study ID

NCT06008795
IRB CED000000829
1U01NS124613-01A1
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Provision of signed and dated ICF by participant or a legally authorizedrepresentative (LAR)

  2. Stated willingness to comply with all study procedures and availability for theduration of the study

  3. Male or female, aged ≥18 and ≤ 85 years

  4. Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hoursof ictus hemorrhage

  5. Disease-specific inclusion criteria:

  6. Spontaneous, non-traumatic SAH

  7. Subarachnoid pattern of hemorrhage warranting diagnostic DSA due to involvementof at least one of the following regions: quadrigeminal plate, prepontinecistern, perimesencephalic cistern, Sylvian fissure, or surrounding Circle ofWillis

  8. Modified Fisher grade 1-4 (on presentation imaging)

  9. 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)

  10. Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)

  11. Able to verbalize pain scale scores according to 11-point numeric pain scale In order to be enrolled and undergo randomization in this study, an individual mustmeet all of the additional criteria:

  12. Stabilization period criteria:

  13. A minimum of 4 hours from DSA with clipping or coiling procedure (wheneverapplicable)

  14. Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration ofaneurysm), when applicable

  15. Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour periodduring eligibility period

Exclusion

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Premorbid conditions:

  2. Pre-existing neurologic, psychiatric, or other condition that would confoundneurologic assessment or would make difficult/impossible to accurately assessneurologic and/or functional outcome

  3. Pre-existing diffuse flow-limiting narrowing of arteries in the Circle ofWillis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moyasyndrome)

  4. Prior use of opioid or barbiturate analgesics for at least two-thirds of thedays in previous month, regardless of indication

  5. Diagnosis of substance use disorder in the previous year

  6. Infected or wounded skin, or a skin lesion at the site of puncture for PPF-injection

  7. Uncorrected coagulopathy

  8. Platelet count < 50,000/μL, International Normalized Ratio (INR) > 1.7

  9. Requiring use of systemic anticoagulation and antiplatelet therapy (except foraspirin monotherapy).

  10. SAH-specific:

  11. Head trauma as etiology of SAH

  12. Infection as cause for aneurysm or SAH (i.e., mycotic aneurysms)

  13. Inability to successfully treat culprit vascular lesion

  14. Diffuse vasospasm on pre-enrollment diagnostic CTA or DSA. Vasospasm is definedas moderate-to-severe arterial narrowing on DSA or CTA not attributable toatherosclerosis, catheter-induced spasm, or vessel hypoplasia, as determined bya neuroradiologist or neurointerventionalist

  15. Standard pain regimen conditions

  16. Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST orALT > 3x upper limit level)

  17. Chronic liver condition with absolute contra-indication for APAP (even at lowermaximum daily doses)

  18. Participation in a concurrent investigational/interventional study (observationalstudies allowed)

  19. Known to be pregnant, or with a positive pregnancy test

  20. Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine,dexamethasone) or standard pain regimen (APAP)

  21. Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)

  22. Unable to receive first PPF-injection within 96 hours of ictus hemorrhage

Study Design

Total Participants: 195
Treatment Group(s): 2
Primary Treatment: Placebo Pteryogpalatine Fossa Injection
Phase: 2
Study Start date:
December 17, 2023
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Mayo Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55009
    United States

    Active - Recruiting

  • Albany Medical College

    Albany, New York 12208
    United States

    Active - Recruiting

  • University of Rochester Medical College

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Oregon Health and Sciences University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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