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

Description

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

Subarachnoid Hemorrhage, Aneurysmal, Headache

Study Overview

Study Details

Study 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)

Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage

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

Condition
Subarachnoid Hemorrhage, Aneurysmal
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Provision of signed and dated informed consent form
  • 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, subarachnoid hemorrhage within 48 hours of ictus hemorrhage
  • 5. Disease-specific
  • 1. 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
  • * Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)
  • * 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
  • 2. Uncorrected coagulopathy
  • * Platelet count \< 50,000/μL, International Normalized Ratio (INR) \> 1.7
  • * Requiring use of systemic anticoagulation and antiplatelet therapy (except for aspirin monotherapy).
  • 3. 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 CTA or digital subtraction angiography (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
  • * 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)
  • 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 (acetaminophen)
  • 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Study Record Dates

2027-02-28