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New treatment option for Subarachnoid Hemorrhage, Aneurysmal
Official title BLOCK-SAH - PPF-Block for Post-SAH Headache
ClinicalTrials.gov ID: NCT06008795
What this study is testing
What is Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone?
Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for subarachnoid hemorrhage, aneurysmal.
Also referred to as Pterygopalatine Fossa Nerve Block.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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
You likely can't join if
- 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...
- Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis...
- 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
See the full eligibility criteria
- 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
- Disease-specific
- 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...
- 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
- 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 \ 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...
- 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/treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
- Miami, Florida, United States
- Stuart, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Omaha, Nebraska, United States
- Rochester, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States; Miami, Florida, United States; Stuart, Florida, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States; Omaha, Nebraska, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.