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NCT07816159
MMA Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal SAH
Conditions: Headaches Associated With Subarachnoid Hemorrhage (SAH)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 90
Sponsor: Rigshospitalet, Denmark
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07816159). StuddyBuddy aggregates publicly available trial information.