Nerve block may ease headaches after brain bleed, reduce opioid use
NCT ID NCT06008795
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tests whether a nerve block injection near the cheek can relieve severe headaches after a brain bleed (subarachnoid hemorrhage). The injection contains a numbing medicine and a steroid. The goal is to see if it reduces the need for opioid painkillers. About 195 adults who recently had a brain bleed will be randomly assigned to get the real injection or a placebo (salt water). The study is double-blind, meaning neither patients nor doctors know who gets which treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ropivacaine and dexamethasone
- What this could lead to
- If it works, this could offer a non-opioid way to manage severe headaches after a brain bleed, reducing reliance on painkillers.
- What could go wrong
- This is an early phase 2 trial, so it's not yet proven. The nerve block may not work better than placebo, and there are risks like bleeding or infection from the injection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 195 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Foundation Martin Health
RECRUITINGStuart, Florida, 34994, United States
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Creighton University Medical Center
RECRUITINGOmaha, Nebraska, 68124, United States
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Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Oregon Health and Sciences University
RECRUITINGPortland, Oregon, 97239, United States
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Thomas Jefferson University
NOT_YET_RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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University of Cincinnati
RECRUITINGCincinnati, Ohio, 45267, United States
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University of Florida
RECRUITINGGainesville, Florida, 32610, United States
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University of Maryland Baltimore
RECRUITINGBaltimore, Maryland, 21201, United States
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27599, United States
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University of Rochester Medical College
RECRUITINGRochester, New York, 14642, United States
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University of Washington
RECRUITINGSeattle, Washington, 98104, United States
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Other studies related to the condition(s) this trial covers.
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