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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Participants will receive lidocaine hydrochloride at a dose of 50 mg per side (10 mg/mL; 5 mL). The infusion is delivered into each MMA over 5 minutes by manual injection, resulting in a total injection time of approximately 10 minutes and a total lidocaine hydrochloride dose of 100 mg. The trial intervention is performed only during the endovascular treatment session. There is no repeated dosing of trial medication.
Participants will receive 5 mL of isotonic saline per side. The infusion is delivered into each MMA over 5 minutes by manual injection, resulting in a total injection time of approximately 10 minutes. The trial intervention is performed only during the endovascular treatment session. There is no repeated dosing of trial medication.
Headache Severity
Daily maximum headache severity over the first 72 hours following the trial intervention
Time frame: From 0 to 72 hours postprocedure
Headache relief
Proportion of participants with headache relief (none to mild headache, NRS≤3) at 2 hours following the trial intervention
Time frame: From baseline to 2 hours postprocedure
Opioid consumption
Total opioid consumption (oral morphine equivalents) during the first 72 hours following the trial intervention
Time frame: From 0-72 hours postprocedure
Patient global assessment
Patient global assessment (PGA) score at 72 hours following the trial intervention. Participants will be asked to respond to the question, "Overall, how do you feel about your level of headache control since the treatment?" using a 5-point scale (poor, fair, good, very good, or excellent).
Time frame: From 0 to 72 hours postprocedure
Adverse Events Related to Intraarterial Lidocaine Injection
Proportion of participants with new onset of facial paresis, facial numbness, diplopia, blurry vision, or dizziness during the first 24 hours following the trial intervention
Time frame: From 0 to 24 hours postprocedure
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