block-sah - ppf-block for post-sah headache

Conditions: Subarachnoid Hemorrhage, Aneurysmal; Headache

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 \ 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

Keywords: pterygopalatine fossa nerve block