Could a simple artery shot replace opioids for Post-Brain bleed headaches?
NCT ID NCT07054801
First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 4 times
Summary
This phase 2 trial tests whether injecting lidocaine and methylprednisolone into the middle meningeal artery can reduce severe headaches after a subarachnoid hemorrhage (a type of brain bleed). The procedure is done during a routine angiogram and aims to lower pain and opioid use. The study will enroll 25 adults with persistent headaches after SAH and track their pain scores for 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lidocaine and methylprednisolone
- What this could lead to
- If it works, this could offer a new way to relieve severe headaches after a brain bleed and reduce the need for opioid painkillers.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply to everyone. The procedure carries risks like any artery injection, and the benefit is not yet proven.
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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 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 years and older
- 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.
Inclusion Criteria: 1. Adults aged ≥18 years with confirmed SAH via computed tomography or magnetic resonance imaging 2. Undergoing DSA as part of routine diagnostic or therapeutic care 3. Experiencing headaches with baseline severity assessable using Headache Impact Test (HIT-6) questionnaire and 11-point Numeric Rating Scale (NRS) 4. Conscious patients who can understand and sign informed consent form 5. Hemodynamically stable and suitable for intra-arterial procedures 5\) Willingness to comply with study procedures and follow-ups Exclusion Criteria: 1. Known allergy or hypersensitivity to lidocaine or amide-type anesthetics 2. Known allergy or hypersensitivity to Intralipid® (intravenous fat emulsion) or any of its components, including egg phospholipids or soy-based products 3. Known allergy or hypersensitivity to methylprednisolone, corticosteroids, any component of the Solu-Medrol® formulation 4. Diagnostic abnormalities at baseline, including ECG abnormalities (e.g., prolonged PR/QTc intervals, heart block, arrhythmias) 5. Cardiac conditions including history of heart block, Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or use of antiarrhythmics 6. Steroid-induced psychiatric history; uncontrolled seizures; uncontrolled diabetes; glaucoma/ocular hypertension; current/recent high-dose systemic steroids. 7. Previous IA lidocaine or methylprednisolone (or similar) therapy prior to enrollment 8. Alternative headache etiology (e.g., migraines, tension-type headache) 9. Unable to report pain reliably due to severe cognitive or communication deficits 10. Severe hemodynamic instability precluding safe DSA participation 11. Contraindications to IA catheterization or DSA (e.g., severe peripheral vascular disease, contrast allergies) 12. Severe renal impairment (eGFR \<30 mL/min/1.73 m²) 13. Severe hepatic impairment (e.g., Child-Pugh Class C) 14. Active systemic infections 15. Severe comorbid conditions with life expectancy \<30 days 16. Participants who are pregnant or breastfeeding 17. Conditions or concomitant medications listed in the USPI for study drugs that would compromise safety or data quality 18. Current participation in another clinical trial
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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
1 site. 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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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
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