Phase
Condition
Stroke
Pain (Pediatric)
Hemorrhage
Treatment
Placebo Pteryogpalatine Fossa Injection
Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Clinical Study ID
Ages 18-85 All Genders
Study Summary
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 authorizedrepresentative (LAR)
Stated willingness to comply with all study procedures and availability for theduration of the study
Male or female, aged ≥18 and ≤ 85 years
Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hoursof ictus hemorrhage
Disease-specific inclusion criteria:
Spontaneous, non-traumatic SAH
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
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 mustmeet all of the additional criteria:
Stabilization period criteria:
A minimum of 4 hours from DSA with clipping or coiling procedure (wheneverapplicable)
Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration ofaneurysm), when applicable
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:
Premorbid conditions:
Pre-existing neurologic, psychiatric, or other condition that would confoundneurologic assessment or would make difficult/impossible to accurately assessneurologic and/or functional outcome
Pre-existing diffuse flow-limiting narrowing of arteries in the Circle ofWillis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moyasyndrome)
Prior use of opioid or barbiturate analgesics for at least two-thirds of thedays 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 foraspirin 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 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
Standard pain regimen conditions
Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST orALT > 3x upper limit level)
Chronic liver condition with absolute contra-indication for APAP (even at lowermaximum daily doses)
Participation in a concurrent investigational/interventional study (observationalstudies 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
Study Design
Connect with a study center
University of Florida
Gainesville, Florida 32610
United StatesActive - Recruiting
Mayo Jacksonville
Jacksonville, Florida 32224
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21287
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55009
United StatesActive - Recruiting
Albany Medical College
Albany, New York 12208
United StatesActive - Recruiting
University of Rochester Medical College
Rochester, New York 14642
United StatesActive - Recruiting
Oregon Health and Sciences University
Portland, Oregon 97239
United StatesActive - Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84132
United StatesActive - Recruiting
University of Washington
Seattle, Washington 98104
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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