Intra-arterial lidocaine and methylprednisolone for SAH-related headaches

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, open-label study evaluating the safety and potential benefit of intra-arterial lidocaine and methylprednisolone given during a diagnostic or therapeutic angiogram for SAH-related headaches. Participants are adults with confirmed SAH who require digital subtraction angiography and have measurable headache severity. The primary outcomes include changes in headache intensity and impact over time, using HIT-6 and an 11-point NRS, along with opioid use and neurological status; secondary outcomes monitor adverse events. The procedure involves placing a microcatheter in the middle meningeal artery and delivering the study drugs under fluoroscopic guidance. Enrollment is limited to those who are stable for intra-arterial procedures and can consent, with follow-ups planned up to 12 weeks post-intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Daniel M S Raper, MBBS — University of California, San Francisco
• Study coordinator: Daniel M S Raper, MBBS
• Email: daniel.raper@ucsf.edu
• Phone: 408-347-4046

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.