Purpose

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)

Conditions

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Sequential Parallel Comparison Design
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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
  • Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
    Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
    Other names:
    • Pterygopalatine Fossa Nerve Block
Other
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
  • Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
    Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
    Other names:
    • Pterygopalatine Fossa Nerve Block
  • Procedure: Placebo Pteryogpalatine Fossa Injection
    Each placebo PPF-injection will consist of 5ml normal saline
Placebo Comparator
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
  • Procedure: Placebo Pteryogpalatine Fossa Injection
    Each placebo PPF-injection will consist of 5ml normal saline

Recruiting Locations

University of Maryland Baltimore
Baltimore 4347778, Maryland 4361885 21201
Contact:
David Oriko
410-328-7822
doriko@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
University of Florida

Study Contact

Yurerkis Montas
617-866-9758
ymontas@partners.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.