Clinical trial NCT06008795: BLOCK-SAH - PPF-Block for Post-SAH Headache
Official title: Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Headache
Keywords: Pterygopalatine Fossa Nerve Block
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: New York University
name: Massachusetts General Hospital
First posted: 2023-08-24
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Parallel Comparison Design
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period
measure: Primary Safety Endpoint
timeFrame: at 48 hours from first PPF-injection (end of double-blinded treatment period)
measure: Primary Tolerability Endpoint
timeFrame: at 24 hours following the first PPF-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical College
state: New York
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: