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

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal, Headache

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Placebo Pteryogpalatine Fossa Injection
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring Pterygopalatine Fossa Nerve Block

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Provision of signed and dated informed consent form 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, subarachnoid hemorrhage within 48 hours of ictus hemorrhage Disease-specific inclusion criteria: Aneurysm identified as culprit of SAH modified Fisher grade 1-4 (on admission imaging) Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on admission, 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: Between 4-48 hours from clipping or coiling procedure (whichever applicable) Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm) Requiring a minimum of 15mg OME prn during the 24-hour period immediately prior to enrollment 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 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, INR > 1.7 requiring use of systemic anticoagulation, ticagrelor or dual antiplatelet therapy 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 initial diagnostic angiography (vasospasm defined as: moderate-to-severe arterial narrowing on digital subtraction angiography not attributable to atherosclerosis, catheter-induced spasm, or vessel hypoplasia, as determined by a neuroradiologist or neurointerventionalist) 118 Standard pain regimen conditions Elevation of hepatic enzymes prohibiting use of scheduled acetaminophen (i.e., AST or ALT > 3x upper limit level) Chronic liver condition with absolute contra-indication for acetaminophen (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 (acetaminophen)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Other

    Placebo Comparator

    Arm Label

    Group 1 - Active - Active

    Group 2 - Placebo - Active

    Group 3 - Placebo - Placebo

    Arm Description

    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

    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

    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

    Outcomes

    Primary Outcome Measures

    Primary Efficacy Endpoint
    prn oral morphine equivalent (OME)/day use
    Primary Safety Endpoint
    incidence of radiographic vasospasm
    Primary Tolerability Endpoint
    rate of acceptance of second PPF-injection

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2023
    Last Updated
    August 18, 2023
    Sponsor
    University of Florida
    Collaborators
    Massachusetts General Hospital, New York University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06008795
    Brief Title
    BLOCK-SAH - PPF-Block for Post-SAH Headache
    Acronym
    BLOCK-SAH
    Official Title
    Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2026 (Anticipated)
    Study Completion Date
    February 28, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    Massachusetts General Hospital, New York University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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) 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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Subarachnoid Hemorrhage, Aneurysmal, Headache
    Keywords
    Pterygopalatine Fossa Nerve Block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Sequential Assignment
    Model Description
    Sequential Parallel Comparison Design
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    195 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 - Active - Active
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Group 2 - Placebo - Active
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    Group 3 - Placebo - Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
    Other Intervention Name(s)
    Pterygopalatine Fossa Nerve Block
    Intervention Description
    Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
    Intervention Type
    Procedure
    Intervention Name(s)
    Placebo Pteryogpalatine Fossa Injection
    Intervention Description
    Each placebo PPF-injection will consist of 5ml normal saline
    Primary Outcome Measure Information:
    Title
    Primary Efficacy Endpoint
    Description
    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
    Title
    Primary Safety Endpoint
    Description
    incidence of radiographic vasospasm
    Time Frame
    at 48 hours from first PPF-injection (end of double-blinded treatment period)
    Title
    Primary Tolerability Endpoint
    Description
    rate of acceptance of second PPF-injection
    Time Frame
    at 24 hours following the first PPF-injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Provision of signed and dated informed consent form 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, subarachnoid hemorrhage within 48 hours of ictus hemorrhage Disease-specific inclusion criteria: Aneurysm identified as culprit of SAH modified Fisher grade 1-4 (on admission imaging) Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on admission, 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: Between 4-48 hours from clipping or coiling procedure (whichever applicable) Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm) Requiring a minimum of 15mg OME prn during the 24-hour period immediately prior to enrollment 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 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, INR > 1.7 requiring use of systemic anticoagulation, ticagrelor or dual antiplatelet therapy 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 initial diagnostic angiography (vasospasm defined as: moderate-to-severe arterial narrowing on digital subtraction angiography not attributable to atherosclerosis, catheter-induced spasm, or vessel hypoplasia, as determined by a neuroradiologist or neurointerventionalist) 118 Standard pain regimen conditions Elevation of hepatic enzymes prohibiting use of scheduled acetaminophen (i.e., AST or ALT > 3x upper limit level) Chronic liver condition with absolute contra-indication for acetaminophen (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 (acetaminophen)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yurerkis Montas
    Phone
    617-866-9758
    Email
    ymontas@partners.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ralisa Pop
    Phone
    352-294-5693
    Email
    ralisa.pop@neurology.ufl.edu

    12. IPD Sharing Statement

    Learn more about this trial

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

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