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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Cohort | Experimental | Intra-arterial 80 mg lidocaine and 40 mg methylprednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine hydrochloride | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Severity | Headache Impact Test-6 (HIT-6) score from baseline (pre-intervention) to 12 weeks postoperatively. Scores range from 36 (no impact) to 78 (severe impact), with higher scores indicating a greater negative impact. | From baseline to 12-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Headache intensity | 11-point Numeric Rating Scale (NRS) score from baseline (pre-intervention) to 12 weeks postoperatively. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scores indicating a greater negative impact. | From baseline to 12-week follow-up |
| Opioid Use |
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Inclusion Criteria:
5) Willingness to comply with study procedures and follow-ups
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel M S Raper, MBBS | Contact | 408-347-4046 | daniel.raper@ucsf.edu | |
| Atakan Orscelik, MD | Contact | 415-353-7500 | atakan.orscelik@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel M S Raper, MBBS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26761719 | Background | 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. | |
| 39819076 | Background |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
|
| Methylprednisolone sodium succinate | 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. |
|
|
Total opioid use will be recorded during hospital stay and follow-up. |
| From admission to 12-week follow-up |
| Functional Outcome | 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. | From discharge to 12-week follow-up |
| Adverse Events Related to Intra-Arterial Injection | 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. | From discharge to 12-week follow-up |
| 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. |
| 37649347 | Background | 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. |
| 41185441 | Background | 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. |
| 34388298 | Background | 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. |
| 30798265 | Background | 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. |
| 33888570 | Background | 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. |
| 25566345 | Background | 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. |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| Aniline Compounds |
| D000588 | Amines |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |