RecruitingPhase 2NCT06008795
BLOCK-SAH - PPF-Block for Post-SAH Headache
Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage
Sponsor
University of Florida
Enrollment
195 participants
Start Date
Dec 17, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria16
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated ICF by participant or a legally authorized representative (LAR)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 and ≤ 85 years
- Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hours of ictus hemorrhage
- Spontaneous, non-traumatic SAH
- 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
- Modified Fisher grade 1-4 (on presentation imaging)
- 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)
- Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)
- 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:
- Stabilization period criteria:
- A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
- Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable
- Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period
Exclusion Criteria23
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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
- 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).
- 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 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
- Standard pain regimen conditions
- Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST or ALT \> 3x upper limit level)
- Chronic liver condition with absolute contra-indication for APAP (even at lower maximum daily doses)
- Participation in a concurrent investigational/interventional study (observational studies allowed)
- Known to be pregnant, or with a positive pregnancy test
- Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (APAP)
- Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
- Unable to receive first PPF-injection within 96 hours of ictus hemorrhage
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGPterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
PROCEDUREPlacebo Pteryogpalatine Fossa Injection
Each placebo PPF-injection will consist of 5ml normal saline
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06008795
Related Trials
Treatment Response in Patients With Medication-Overuse Headache
NCT074876491 location
Mind Body Balance for Pediatric Migraine
NCT047156852 locations
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms
NCT074790821 location
Responding With Evidence and Access for Childhood Headaches
NCT0588962415 locations
Personalized Brain Stimulation to Treat Chronic Concussive Symptoms
NCT060738861 location