[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655616":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":41,"studyPopulation":29,"armGroups":42,"interventions":55,"overallOfficials":29,"centralContacts":65,"locations":29,"responsibleParty":72,"collaborators":29,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":29,"enrollmentInfo":86,"targetDuration":29,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":102,"whyStopped":29,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":29},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Headache Severity","Daily maximum headache severity over the first 72 hours following the trial intervention","From 0 to 72 hours postprocedure",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Headache relief","Proportion of participants with headache relief (none to mild headache, NRS≤3) at 2 hours following the trial intervention","From baseline to 2 hours postprocedure",{"measure":19,"description":20,"timeFrame":21},"Opioid consumption","Total opioid consumption (oral morphine equivalents) during the first 72 hours following the trial intervention","From 0-72 hours postprocedure",{"measure":23,"description":24,"timeFrame":12},"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).",{"measure":26,"description":27,"timeFrame":28},"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","From 0 to 24 hours postprocedure",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":36},"QUADRUPLE",[37,38,39,40],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nSAH-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.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"MMA lidocaine","EXPERIMENTAL","The participants will receive 50 mg of lidocaine in each middle meningeal artery",[48],"Drug: Lidocaine hydrochloride",{"label":50,"type":51,"description":52,"interventionNames":53},"MMA isotonic saline","PLACEBO_COMPARATOR","The participants will receive isotonic saline in each middle meningeal artery",[54],"Drug: Isotonic saline",[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":29},"DRUG","Lidocaine hydrochloride","Participants will receive lidocaine hydrochloride at a dose of 50 mg per side (10 mg\u002FmL; 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.",[44],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":29},"Isotonic 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.",[50],[66],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"Rasmus H Dahl","CONTACT","35456491","0045","rasmus.holmboe.dahl@regionh.dk",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Rasmus Holmboe Dahl","Medical Doctor","100655616","phase-2-mma-infusion-of-lidocaine-for-treatment-of-headache-in-patients-with-aneurysmal-sah-100655616",false,"NCT07816159","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","MIL-SAH","Inclusion criteria\n\n1. Age ≥ 18 years\n2. Imaging showing a SAH and intracranial aneurysm\n3. Undergo endovascular therapy within 72 hours\\*\n4. Glasgow coma scale (GCS) score of 14-15\n5. Maximum headache severity of NRS score ≥ 4 at a time \\> 1 hour after ictus or the ad-ministration of opioids due to headache\n\n   Exclusion criteria\n6. The patient is unable to understand information provided in the national language or English\n7. Known allergies to amide-type local anesthetics or iodinated contrast media\n8. Pregnancy or lactation\n9. Severe hepatic impairment\n10. History of epilepsy\n11. History of chronic opioid use\n12. Renal impairment with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2\n13. Current treatment with class III antiarrhythmics (e.g. amiodarone)\n14. Atrioventricular block of II and III degree\n15. Unsuccessful endovascular aneurysm securement or procedural complications","ALL","18 Years",{"count":87,"type":88},90,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","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.",[94],"Headaches Associated With Subarachnoid Hemorrhage (SAH)",[96,97,98,99,100,101],"subarachnoid hemorrhage","lidocaine","middle meningeal artery","SAH","MMA","headache","NOT_YET_RECRUITING","2026-09-07",{"date":105,"type":106},"2026-09-11","ACTUAL",{"date":108,"type":88},"2026-12",{"date":110,"type":88},"2030-02",{"name":5,"class":6}]