IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage

Recruiting now · Phase 2

Conditions studied: Headaches Associated With Subarachnoid Hemorrhage (SAH)

In brief

Subarachnoid hemorrhage (SAH) is a type of bleeding around the brain that can cause sudden and severe headaches. These headaches can be debilitating and persist for weeks, significantly impacting a patient's comfort and recovery. Many patients require opioids for pain control, which can lead to side effects such as drowsiness, constipation, and dependency. There is a need for new treatment strategies to help relieve this pain while minimizing side effects. This clinical study is designed to evaluate whether an injection of two medications (lidocaine and methylprednisolone) directly into the middle meningeal artery (MMA) can help reduce headache severity in patients who recently experienced a SAH. The medications will be given through a minimally invasive procedure performed during a routine angiogram, a type of imaging test already commonly used in SAH patients. The main goals of the study are to determine whether this treatment approach is safe, helps to reduce the severity of headaches, and decreases the need for opioid pain medications. Eligible patients will be those recently diagnosed with persistent headache symptoms and SAH who are undergoing routine cerebral angiogram, during which the medications are infused into the MMA. Participants will be monitored for pain levels using the Headache Impact Test (HIT-6) and 11-point Numeric Rating Scale (NRS), and for changes in their functional recovery using standard neurologic scales. The results of this study may provide early evidence to support new treatment options for patients suffering from difficult-to-control headaches after a SAH.

Key facts

Study ID: NCT07054801
Run by: Daniel Raper, MBBS
People needed: 25
Starts: 2026-06-23
Expected to finish: 2027-06-01
Last updated by the study team: 2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of California, San Francisco — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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