Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
195 participants
INTERVENTIONAL
2023-12-17
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Group 1 - Active - Active
Subjects randomized to Group 1 will receive an active PPF nerve block in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
Group 2 - Placebo - Active
Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
Placebo Pteryogpalatine Fossa Injection
Each placebo PPF-injection will consist of 5ml normal saline
Group 3 - Placebo - Placebo
Subjects randomized to Group 3 will receive a placebo PPF-injection in Stage 1 followed by a placebo PPF-injection in Stage 2 of the Double-Blinded Trial Phase
Placebo Pteryogpalatine Fossa Injection
Each placebo PPF-injection will consist of 5ml normal saline
Interventions
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Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
Placebo Pteryogpalatine Fossa Injection
Each placebo PPF-injection will consist of 5ml normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration 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 hours of ictus hemorrhage
1. 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)
5. Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)
6. 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:
7. Stabilization period criteria:
1. A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
2. Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable
8. Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period
Exclusion Criteria
1. Premorbid conditions:
1. 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
2. Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)
3. Prior use of opioid or barbiturate analgesics for at least two-thirds of the days in previous month, regardless of indication
4. Diagnosis of substance use disorder in the previous year
5. Infected or wounded skin, or a skin lesion at the site of puncture for PPF- injection
2. Uncorrected coagulopathy
1. Platelet count \< 50,000/μL, International Normalized Ratio (INR) \> 1.7
2. Requiring use of systemic anticoagulation and antiplatelet therapy (except for aspirin monotherapy).
3. SAH-specific:
1. Head trauma as etiology of SAH
2. Infection as cause for aneurysm or SAH (i.e., mycotic aneurysms)
3. Inability to successfully treat culprit vascular lesion
4. 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
4. Standard pain regimen conditions
1. Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST or ALT \> 3x upper limit level)
2. Chronic liver condition with absolute contra-indication for APAP (even at lower maximum daily doses)
5. Participation in a concurrent investigational/interventional study (observational studies allowed)
6. Known to be pregnant, or with a positive pregnancy test
7. Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (APAP)
8. Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
9. Unable to receive first PPF-injection within 96 hours of ictus hemorrhage
18 Years
85 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
New York University
OTHER
Massachusetts General Hospital
OTHER
University of Florida
OTHER
Responsible Party
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Locations
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University of Florida
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Albany Medical College
Albany, New York, United States
University of Rochester Medical College
Rochester, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Busl KM, Smith CR, Troxel AB, Fava M, Illenberger N, Pop R, Yang W, Frota LM, Gao H, Shan G, Hoh BL, Maciel CB; BLOCK-SAH Investigators. Rationale and Design for the BLOCK-SAH Study (Pterygopalatine Fossa Block as an Opioid-Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage): A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial with a Sequential Parallel Comparison Design. Neurocrit Care. 2025 Feb;42(1):290-300. doi: 10.1007/s12028-024-02078-z. Epub 2024 Aug 13.
Other Identifiers
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IRB CED000000829
Identifier Type: -
Identifier Source: org_study_id
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