Phase
Condition
Stroke
Pain (Pediatric)
Hemorrhage
Treatment
Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Placebo Pteryogpalatine Fossa Injection
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 StatesSite Not Available
Mayo Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
University of Florida
Gainesville 4156404, Florida 4155751 32610
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Emory University
Atlanta 4180439, Georgia 4197000 30322
United StatesActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available
University of Maryland Baltimore
Baltimore 4347778, Maryland 4361885 21201
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55009
United StatesActive - Recruiting
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55009
United StatesActive - Recruiting
Albany Medical College
Albany, New York 12208
United StatesSite Not Available
University of Rochester Medical College
Rochester, New York 14642
United StatesSite Not Available
Albany Medical College
Albany 5106834, New York 5128638 12208
United StatesActive - Recruiting
University of Rochester Medical College
Rochester 5134086, New York 5128638 14642
United StatesActive - Recruiting
University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45267
United StatesActive - Recruiting
Oregon Health and Sciences University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health and Sciences University
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
University of Washington
Seattle, Washington 98104
United StatesSite Not Available
University of Washington
Seattle 5809844, Washington 5815135 98104
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.