Lidocaine Infusion As A Treatment Modality For Headache Following Non-Traumatic Subarachnoid Hemorrhage: A Prospective, Single-Center, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction of pain
研究概览
简要总结
The goal of this observational study is to evaluate intravenous lidocaine efficacy and safety in treating headache following non-traumatic subarachnoid hemorrhage. Through this prospective analysis, the investigators hope to:
- show that intravenous lidocaine infusion causes a clinically significant reduction in pain scores in patients with moderate/severe headache pain following non-traumatic subarachnoid hemorrhage;
- show that intravenous lidocaine infusion is safe in treating headache following non-traumatic subarachnoid hemorrhage;
- and report vasospasm prevalence in the cohort.
Participants will receive lidocaine infusion as treatment for non-traumatic subarachnoid hemorrhage headache and provide pain scores (on a numeric pain scale) every two hours the patients are awake for a maximum of seven days. Monitoring for vasospasm will occur as part of the patients regular medical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients > 18 years;
- •Have a favorable neurological status defined as Hunt and Hess score ≤ 3 (as it accounts for patient awareness);
- •Can communicate numeric pain scores;
- •Are diagnosed with non-traumatic subarachnoid hemorrhage
排除标准
- •The patient is diagnosed with traumatic subarachnoid hemorrhage;
- •If the patient is < 18 years of age;
- •If numeric pain scores could not be captured for > 3 days of hospitalization;
- •If the patient had a prior aneurysm;
- •Chronic pain not associated with non-traumatic subarachnoid hemorrhage diagnosis;
- •A disability before the stroke (> 2 on modified Rankin Scale score);
- •A Hunt and Hess score > 3;
- •Contraindications to lidocaine (significant cardiac disease, arrhythmia, seizures, previous allergic reaction to lidocaine
结局指标
主要结局
Reduction of pain
时间窗: Benefit should be seen within first 24 h of infusion
Reduction of pain ≥ 2 points in the numeric pain score after lidocaine infusion treatment. The numeric pain score is a score rating severity of pain from 0 to 10, with higher scores meaning worse pain. The reduction in pain scores indicates a decrease in severity of pain.
Reduction of pain
时间窗: Benefit should be seen within first 24 h of infusion
Reduction of pain ≥ 2 points in the numeric pain score after lidocaine infusion treatment. The numeric pain score is a score rating severity of pain from 0 to 10, with higher scores meaning worse pain. The reduction in pain scores indicates a decrease in severity of pain.
次要结局
未报告次要终点