Headaches Associated With Subarachnoid Hemorrhage (SAH)
Conditions
Keywords
subarachnoid hemorrhage, lidocaine, middle meningeal artery, SAH, MMA, headache
Brief summary
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.
Detailed description
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.
Interventions
DRUGLidocaine hydrochloride
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.
DRUGIsotonic saline
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.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Severity | From 0 to 72 hours postprocedure | Daily maximum headache severity over the first 72 hours following the trial intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache relief | From baseline to 2 hours postprocedure | Proportion of participants with headache relief (none to mild headache, NRS≤3) at 2 hours following the trial intervention |
| Opioid consumption | From 0-72 hours postprocedure | Total opioid consumption (oral morphine equivalents) during the first 72 hours following the trial intervention |
| Patient global assessment | From 0 to 72 hours postprocedure | 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). |
| Adverse Events Related to Intraarterial Lidocaine Injection | From 0 to 24 hours postprocedure | 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 |
Contacts
CONTACTRasmus H Dahl
Outcome results
None listed