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Status:

RECRUITING

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

Lead Sponsor:

University of Florida

Collaborating Sponsors:

National Institute of Neurological Disorders and Stroke (NINDS)

New York University

Conditions:

Subarachnoid Hemorrhage, Aneurysmal

Headache

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

Brief 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) injecti...

Eligibility Criteria

Inclusion

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Provision of signed and dated ICF by participant or a legally authorized representative (LAR)
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged ≥18 and ≤ 85 years
  • Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hours of ictus hemorrhage
  • Disease-specific inclusion criteria:
  • Spontaneous, non-traumatic SAH
  • 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
  • Modified Fisher grade 1-4 (on presentation imaging)
  • 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)
  • Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)
  • 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 must meet all of the additional criteria:
  • Stabilization period criteria:
  • A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
  • Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable
  • Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period
  • Exclusion Criteria:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 17 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    February 28 2027

    Estimated Enrollment :

    195 Patients enrolled

    Trial Details

    Trial ID

    NCT06008795

    Start Date

    December 17 2023

    End Date

    February 28 2027

    Last Update

    November 28 2025

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    University of Florida

    Gainesville, Florida, United States, 32610

    2

    Emory University

    Atlanta, Georgia, United States, 30322

    3

    University of Maryland Baltimore

    Baltimore, Maryland, United States, 21201

    4

    Mayo Clinic

    Rochester, Minnesota, United States, 55009