Pterygopalatine fossa nerve block for headaches after subarachnoid hemorrhage

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

This study is testing if a special nerve block can help people who have had a brain bleed feel better by reducing their headaches.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 11 sites (Gainesville, Florida and 10 other locations)
• Trial ID: NCT06008795 on ClinicalTrials.gov

What this trial studies

BLOCK-SAH is a phase II clinical trial that investigates the effectiveness of bilateral pterygopalatine fossa injections using ropivacaine and dexamethasone compared to a saline placebo in treating headaches in patients who have survived an aneurysmal subarachnoid hemorrhage. The study employs a randomized, double-blinded, placebo-controlled design and monitors intracranial arterial mean flow velocities using transcranial Doppler ultrasound during the intervention. Participants must be admitted with a primary diagnosis of spontaneous, non-traumatic SAH within 48 hours of the hemorrhage. The trial aims to assess the potential benefits of this nerve block technique in alleviating post-SAH headaches.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who have been diagnosed with spontaneous, non-traumatic subarachnoid hemorrhage within 48 hours of the event.

Not a fit: Patients with traumatic SAH or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce headache severity and improve quality of life for patients recovering from subarachnoid hemorrhage.

How similar studies have performed: Other studies have shown promise in using nerve blocks for headache management, suggesting potential success for this approach.

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

Where this trial is running

Gainesville, Florida and 10 other locations

• University of Florida — Gainesville, Florida, United States (Recruiting)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• University of Maryland Baltimore — Baltimore, Maryland, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Albany Medical College — Albany, New York, United States (Recruiting)
• University of Rochester Medical College — Rochester, New York, United States (Recruiting)
• University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
• Oregon Health and Sciences University — Portland, Oregon, United States (Recruiting)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
• University of Washington — Seattle, Washington, United States (Recruiting)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Yurerkis Montas

Conditions Subarachnoid Hemorrhage, Aneurysmal; Headache; Pterygopalatine Fossa Nerve Block