MMA Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal SAH
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Imaging showing a SAH and intracranial aneurysm
Undergo endovascular therapy within 72 hours*
Glasgow coma scale (GCS) score of 14-15
Disqualifiers
The patient is unable to understand information provided in the national language or English
Known allergies to amide-type local anesthetics or iodinated contrast media
Pregnancy or lactation
Severe hepatic impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine hydrochloride
DrugParticipants 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.
Isotonic saline
DrugParticipants 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: MMA lidocaineExperimental treatment 1 intervention
Group B: MMA isotonic salinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Headache Severity
Daily maximum headache severity over the first 72 hours following the trial intervention
Time frame
From 0 to 72 hours postprocedureSecondary outcomes
1
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 postprocedure2
Opioid consumption
Total opioid consumption (oral morphine equivalents) during the first 72 hours following the trial intervention
Time frame
From 0-72 hours postprocedure3
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 postprocedure4
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 postprocedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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