IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage

Официальное название

Intra-arterial Lidocaine and Methylprednisolone Injection Into the Middle Meningeal Artery For Treatment of Headache Associated With Subarachnoid Hemorrhage

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Headache Severity [Срок оценки: From baseline to 12-week follow-up]

Вторичные конечные точки (4)

• Headache intensity [Срок оценки: From baseline to 12-week follow-up]
• Opioid Use [Срок оценки: From admission to 12-week follow-up]
• Functional Outcome [Срок оценки: From discharge to 12-week follow-up]
• Adverse Events Related to Intra-Arterial Injection [Срок оценки: From discharge to 12-week follow-up]

Критерии участия

Критерии включения

• 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

5\) Willingness to comply with study procedures and follow-ups

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Публикации

• Laemmel E, Segal N, Mirshahi M, Azzazene D, Le Marchand S, Wybier M, Vicaut E, Laredo JD. Deleterious Effects of Intra-arterial Administration of Particulate Steroids on Microvascular Perfusion in a Mouse Model. Radiology. 2016 Jun;279(3):731-40. doi: 10.1148/radiol.2015142746. Epub 2016 Jan 13. PMID 26761719
• Qureshi AI, Bains NK, Bhatti IA, Jani V, Suri MFK, Bhogal P. Intra-arterial lidocaine administration of lidocaine in middle meningeal artery for short-term treatment of subarachnoid hemorrhage-related headaches. Interv Neuroradiol. 2025 Jan 17:15910199241307049. doi: 10.1177/15910199241307049. Online ahead of print. PMID 39819076
• Diana F, Romoli M, Ricchetti F, Milonia L, Salcuni A, Cirelli C, Ruzza AD, Gaudino C, Iacobucci M, Biraschi F. Lidocaine for headache prevention during chronic subdural hematoma embolization. Interv Neuroradiol. 2026 Feb;32(1):100-103. doi: 10.1177/15910199231198909. Epub 2023 Aug 30. PMID 37649347
• Fakih R, Ranjini NJ, Gillani SA, Pfeiffer K, Gomez CR, Sirakov A, Suri MFK, Bhogal P, Qureshi AI. Middle Meningeal Artery Lidocaine Infusion for Refractory Migraine: Angiographic Dose Response and 3-Month Outcomes. J Neuroimaging. 2025 Nov-Dec;35(6):e70096. doi: 10.1111/jon.70096. PMID 41185441
• Qureshi AI, Pfeiffer K, Babar S, Huang W, Lobanova I, Ishfaq MF, French BR, Siddiq F, Gomez CR. Intra-arterial injection of lidocaine into middle meningeal artery to treat intractable headaches and severe migraine. J Neuroimaging. 2021 Nov;31(6):1126-1134. doi: 10.1111/jon.12918. Epub 2021 Aug 13. PMID 34388298
• Fiorella D, Arthur AS. Middle meningeal artery embolization for the management of chronic subdural hematoma. J Neurointerv Surg. 2019 Sep;11(9):912-915. doi: 10.1136/neurintsurg-2019-014730. Epub 2019 Feb 23. PMID 30798265
• Catapano JS, Karahalios K, Srinivasan VM, Baranoski JF, Rutledge C, Cole TS, Ducruet AF, Albuquerque FC, Jadhav AP. Chronic headaches and middle meningeal artery embolization. J Neurointerv Surg. 2022 Mar;14(3):301-303. doi: 10.1136/neurintsurg-2021-017602. Epub 2021 Apr 22. PMID 33888570
• Qureshi AI, Qureshi MH, Khan AA, Suri MF. Effect of intra-arterial injection of lidocaine and methyl-prednisolone into middle meningeal artery on intractable headaches. J Vasc Interv Neurol. 2014 Dec;7(5):69-72. PMID 25566345

Идентификаторы

NCT: NCT07054801 · 23-40755

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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