IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage

NCT ID: NCT07054801

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2027-12-01

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 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.

Detailed Description

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 using the HIT-6 score at baseline (pre-intervention), discharge, and at 1, 6, and 12 weeks postoperatively. 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.

Conditions

Headaches Associated With Subarachnoid Hemorrhage (SAH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Cohort

Intra-arterial 80 mg lidocaine and 40 mg methylprednisolone

Group Type: EXPERIMENTAL

Lidocaine hydrochloride

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Xylocaine-MPF; Solu-MEDROL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daniel Raper, MBBS

OTHER

Sponsor Role: lead

Responsible Party

Daniel Raper, MBBS

Assistant Professor, Neurological Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniel Raper, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Central Contacts

Daniel Raper, MBBS

Role: CONTACT

daniel.raper@ucsf.edu

408-347-4046

Atakan Orscelik, MD

Role: CONTACT

atakan.orscelik@ucsf.edu

415-885-3515

Facility Contacts

Daniel Raper, MBBS

Role: primary

daniel.raper@ucsf.edu

408-347-4046

Atakan Orscelik, MD

Role: backup

atakan.orscelik@ucsf.edu

Other Identifiers

23-40755

Identifier Type: -

Identifier Source: org_study_id