MMA Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal SAH

Middle Meningeal Artery Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal Subarachnoid Hemorrhage

The purpose of the MIL-SAH trial is to evaluate the efficacy and safety of middle meningeal artery (MMA) lidocaine infusion for the treatment of headache in patients with aneurysmal subarachnoid hemorrhage (SAH). The trial aims to determine whether MMA lidocaine infusion reduces headache severity during the first 72 hours following endovascular aneurysm treatment compared with placebo.

The MIL-SAH trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating whether middle meningeal artery (MMA) infusion of lidocaine reduces headache severity in patients with aneurysmal subarachnoid hemorrhage (SAH). Adult patients with SAH undergoing endovascular aneurysm treatment are randomized to receive either bilateral MMA lidocaine infusion or placebo immediately after successful aneurysm securement.

SAH-related headaches are frequently severe, persistent, and difficult to control with current analgesic strategies, which often rely on opioids. Preliminary case series have suggested that MMA lidocaine infusion may reduce headache severity with few adverse effects, but randomized clinical trials to support this is currently lacking. This trial aims to provide robust data on the efficacy and safety of this novel treatment approach.

Inclusion criteria

1. Age ≥ 18 years

2. Imaging showing a SAH and intracranial aneurysm

3. Undergo endovascular therapy within 72 hours*

4. Glasgow coma scale (GCS) score of 14-15

5. Maximum headache severity of NRS score ≥ 4 at a time > 1 hour after ictus or the ad-ministration of opioids due to headache

   Exclusion criteria

6. The patient is unable to understand information provided in the national language or English

7. Known allergies to amide-type local anesthetics or iodinated contrast media

8. Pregnancy or lactation

9. Severe hepatic impairment

10. History of epilepsy

11. History of chronic opioid use

12. Renal impairment with eGFR < 30 mL/min/1.73m2

13. Current treatment with class III antiarrhythmics (e.g. amiodarone)

14. Atrioventricular block of II and III degree

15. Unsuccessful endovascular aneurysm securement or procedural complications