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)
Eligibility
Inclusion 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 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 inclusion criteria:
1. Aneurysm identified as culprit of SAH
2. Modified Fisher grade 1-4 (on admission imaging)
3. 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)
4. 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 clipping or coiling procedure (whichever applicable)
2. Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of
aneurysm)
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:
- 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