Recruiting
Phase 2

Lidocaine & Methylprednisolone

Sponsor:

Daniel Raper, MBBS

Code:

NCT07054801

Conditions

Headaches Associated With Subarachnoid Hemorrhage (SAH)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine hydrochloride

Methylprednisolone sodium succinate

Study Details

Brief summary:

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.

Conditions

Headaches Associated With Subarachnoid Hemorrhage (SAH)

Study ID

NCT07054801

Start date

Jun 23, 2026

Status verified date

Jul, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Cohort

Intra-arterial 80 mg lidocaine and 40 mg methylprednisolone

Interventions

Lidocaine hydrochloride

A total of 20 mg injected in 10 mg doses will be administered over 5 min into the frontal and parietal branches of each MMA, resulting in a cumulative dose of 40 mg per MMA. The injection will be performed bilaterally, yielding a total dose of 80 mg per patient.

Methylprednisolone sodium succinate

A total of 10 mg were injected over 5 min into the frontal and parietal branches of each MMA, resulting in a cumulative dose of 20 mg per MMA, yielding a total dose of 40 mg per patient.

Primary outcome measure

  • Headache Severity [ Time Frame: From baseline to 12-week follow-up ]

Central Contacts and Locations

Central contacts

Daniel M S Raper, MBBS

408-347-4046daniel.raper@ucsf.edu

Atakan Orscelik, MD

415-353-7500atakan.orscelik@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Daniel M S Raper, MBBS

408-347-4046daniel.raper@ucsf.edu

Atakan Orscelik, MD

415-353-7500atakan.orscelik@ucsf.edu

Principal Investigator:

Daniel M S Raper, MBBS

More Information

Sponsor

Daniel Raper, MBBS

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Headache
  • Subarachnoid hemorrhage
  • Lidocaine
  • Methylprednisolone
  • Intra-arterial
  • Middle meningeal artery
  • Digital subtraction angiography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Daniel Raper, MBBS on 2026-07-08.