IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage

This is a single-center, prospective, single-arm, open-label clinical trial evaluating the safety and efficacy of intra-arterial administration of lidocaine and methylprednisolone sodium succinate via the MMA for the treatment of moderate or severe headaches associated with SAH. Eligible participants will include adult patients diagnosed with SAH who are undergoing diagnostic or therapeutic digital subtraction angiography (DSA). During the DSA procedure, following routine angiographic imaging, a microcatheter will be placed in the MMA, and a low dose of lidocaine and methylprednisolone will be slowly infused under fluoroscopic guidance.

The primary outcome will assess the change in headache severity and intensity using the HIT-6 score and 11-point NRS at baseline (pre-intervention), discharge, and at follow-up visits at days 1-10, Weeks 2, 4 and 12. Secondary outcomes will include reduction in opioid use, neurological outcome measured by the modified Rankin Scale at discharge and follow-up, and the incidence of any adverse events related to the procedure.

Inclusion criteria

• Adults aged ≥18 years with confirmed SAH via computed tomography or magnetic resonance imaging
• Undergoing DSA as part of routine diagnostic or therapeutic care
• Experiencing headaches with baseline severity assessable using Headache Impact Test (HIT-6) questionnaire and 11-point Numeric Rating Scale (NRS)
• Conscious patients who can understand and sign informed consent form
• Hemodynamically stable and suitable for intra-arterial procedures

• Willingness to comply with study procedures and follow-ups

Exclusion criteria

• Known allergy or hypersensitivity to lidocaine or amide-type anesthetics
• Known allergy or hypersensitivity to Intralipid® (intravenous fat emulsion) or any of its components, including egg phospholipids or soy-based products
• Known allergy or hypersensitivity to methylprednisolone, corticosteroids, any component of the Solu-Medrol® formulation
• Diagnostic abnormalities at baseline, including ECG abnormalities (e.g., prolonged PR/QTc intervals, heart block, arrhythmias)
• Cardiac conditions including history of heart block, Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or use of antiarrhythmics
• Steroid-induced psychiatric history; uncontrolled seizures; uncontrolled diabetes; glaucoma/ocular hypertension; current/recent high-dose systemic steroids.
• Previous IA lidocaine or methylprednisolone (or similar) therapy prior to enrollment
• Alternative headache etiology (e.g., migraines, tension-type headache)
• Unable to report pain reliably due to severe cognitive or communication deficits
• Severe hemodynamic instability precluding safe DSA participation
• Contraindications to IA catheterization or DSA (e.g., severe peripheral vascular disease, contrast allergies)
• Severe renal impairment (eGFR <30 mL/min/1.73 m²)
• Severe hepatic impairment (e.g., Child-Pugh Class C)
• Active systemic infections
• Severe comorbid conditions with life expectancy <30 days
• Participants who are pregnant or breastfeeding
• Conditions or concomitant medications listed in the USPI for study drugs that would compromise safety or data quality
• Current participation in another clinical trial