Middle Meningeal Artery Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Headache Severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Imaging showing a SAH and intracranial aneurysm
- •Undergo endovascular therapy within 72 hours*
- •Glasgow coma scale (GCS) score of 14-15
- •Maximum headache severity of NRS score ≥ 4 at a time > 1 hour after ictus or the ad-ministration of opioids due to headache
排除标准
- •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
- •History of epilepsy
- •History of chronic opioid use
- •Renal impairment with eGFR < 30 mL/min/1.73m2
- •Current treatment with class III antiarrhythmics (e.g. amiodarone)
- •Atrioventricular block of II and III degree
- •Unsuccessful endovascular aneurysm securement or procedural complications
研究组 & 干预措施
MMA isotonic saline
The participants will receive isotonic saline in each middle meningeal artery
干预措施: Isotonic saline (Drug)
MMA lidocaine
The participants will receive 50 mg of lidocaine in each middle meningeal artery
干预措施: Lidocaine hydrochloride (Drug)
结局指标
主要结局
Headache Severity
时间窗: From 0 to 72 hours postprocedure
Daily maximum headache severity over the first 72 hours following the trial intervention
次要结局
- Headache relief(From baseline to 2 hours postprocedure)
- Opioid consumption(From 0-72 hours postprocedure)
- Patient global assessment(From 0 to 72 hours postprocedure)
- Adverse Events Related to Intraarterial Lidocaine Injection(From 0 to 24 hours postprocedure)
研究者
Rasmus Holmboe Dahl
Medical Doctor
Rigshospitalet, Denmark