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

Phase 2RecruitingNCT06008795
University of Florida195 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

195

Conditions

Subarachnoid Hemorrhage, AneurysmalHeadache

Interventions

Pterygopalatine Fossa Nerve Block with Ropivacaine and DexamethasoneDRUG

Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone

Placebo Pteryogpalatine Fossa InjectionPROCEDURE

Each placebo PPF-injection will consist of 5ml normal saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years
Medical Language ↔ Plain English
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 authorized representative (LAR) 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 5. Disease-specific inclusion criteria: 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: An individual who meets any of the following criteria will be excluded from participation in this study: 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

Locations (13)

University of Florida

Gainesville, Florida, United States

RECRUITING

University of Miami

Miami, Florida, United States

RECRUITING

Cleveland Clinic Foundation Martin Health

Stuart, Florida, United States

RECRUITING

Emory University

Atlanta, Georgia, United States

RECRUITING

University of Maryland Baltimore

Baltimore, Maryland, United States

RECRUITING

Creighton University Medical Center

Omaha, Nebraska, United States

RECRUITING

University of Rochester Medical College

Rochester, New York, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

RECRUITING

Oregon Health and Sciences University

Portland, Oregon, United States

RECRUITING

...and 3 more locations

Outcomes

Primary Outcomes

Primary Efficacy Endpoint

prn oral morphine equivalent (OME)/day use

Time frame: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period

Primary Safety Endpoint

incidence of radiographic vasospasm

Time frame: at 48 hours from first PPF-injection (end of double-blinded treatment period)

Primary Tolerability Endpoint

rate of acceptance of second PPF-injection

Time frame: at 24 hours following the first PPF-injection

Central Contacts

Yurerkis Montas

CONTACT

617-866-9758ymontas@partners.org

Ralisa Pop

CONTACT

352-294-5693ralisa.pop@neurology.ufl.edu
Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.