IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage

Not Applicable

Not yet recruiting

• Conditions: Headaches Associated With Subarachnoid Hemorrhage (SAH)
• Interventions: Drug: Lidocaine hydrochloride; Drug: Methylprednisolone sodium succinate

• Registration Number: NCT07054801
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2025-06-27
• Study First Submitted QC: 2025-06-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-10
• Study Start: 2025-11-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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 HIT-6 questionnaire
4. 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. Alternative headache etiology (e.g., migraines, tension-type headache)
3. Severe hemodynamic instability precluding safe DSA participation
4. Contraindications to intra-arterial catheterization or DSA (e.g., severe peripheral vascular disease or contrast allergies)
5. Severe renal impairment (eGFR <30 mL/min/1.73 m²)
6. Severe hepatic impairment (Child-Pugh Class C)
7. Pregnancy or lactation
8. Severe comorbid conditions with life expectancy <30 days
9. Current participation in another interventional clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Cohort	Lidocaine hydrochloride	Intra-arterial 80 mg lidocaine and 40 mg methylprednisolone
Treatment Cohort	Methylprednisolone sodium succinate	Intra-arterial 80 mg lidocaine and 40 mg methylprednisolone

Primary Outcome Measures

Name	Time	Method
Headache Severity	From baseline to 12-week follow-up	Headache Impact Test-6 score at baseline (pre-intervention), discharge, and at 1, 6, and 12 weeks postoperatively. Scores range from 36 (no impact) to 78 (severe impact), with higher scores indicating a greater negative impact.

Secondary Outcome Measures

Name	Time	Method
Opioid Use	From admission to 12-week follow-up	Total opioid use will be recorded during hospital stay and follow-up.
Functional Outcome	From discharge to 12-week follow-up	Functional status will be assessed using the modified Rankin Scale at discharge and follow-up. Scores range from 0 (no symptoms) to 6 (death), with lower scores indicating better outcomes.
Adverse Events Related to Intra-Arterial Injection	From discharge to 12-week follow-up	All procedural and post-procedural complications will be monitored, including symptoms of lidocaine toxicity, new neurological deficits, worsening headache, hemodynamic instability, or allergic reactions. Events will be categorized by severity and attribution to the intervention.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States