Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Score
研究概览
简要总结
The goal of this clinical trial is to learn if an infusion of lidocaine, with or without steroids, into the middle meningeal artery (MMA) helps relieve severe headaches in patients with spontaneous subarachnoid hemorrhage (SAH). It will also study the safety of this treatment.
详细描述
This protocol outlines a single-arm prospective cohort study evaluating the efficacy of endovascular infusion of lidocaine and steroids into the MMA for managing post-SAH pain (i.e., headaches) in patients with SAH with Hunt and Hess Grades 1-2. 15 patients will be enrolled into three groups of treatment: lidocaine, lidocaine/dexamethasone, and no injection. Pain outcomes will be evaluated using VAS at multiple timepoints, including during neurochecks postoperatively, to calculate a cumulative "total VAS score." Morphine equivalents will also be tracked to assess opioid needs over time.
The main questions it aims to answer are:
Does the infusion lower patients' pain levels after SAH?
Does the infusion reduce the amount of opioids and other pain medications patients need?
Are there any side effects or complications from the procedure?
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Diagnosed with aneurysmal SAH, Hunt and Hess Grades 1-
- •Consent to study procedures and follow-up evaluations.
排除标准
- •Known allergies to lidocaine or steroids.
- •Arteriovenous malformations.
- •Dural Arteriovenous Fistulas.
- •Other significant intracranial pathologies.
- •Hemodynamic instability preventing safe intervention.
- •Previous MMA interventions.
- •Previous craniotomies or need for craniotomy.
- •Need for external ventricular drain.
研究组 & 干预措施
Lidocaine (50 mg bilaterally)
The participants will receive 50 mg of lidocaine.
干预措施: Lidocaine (Drug)
Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)
The participant will receive Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)
干预措施: Lidocaine and Dexamethasone (Drug)
No injection (Control group)
The participant will not receive an injection.
结局指标
主要结局
Visual Analog Scale (VAS) Score
时间窗: Baseline
The Visual Analog Scale (VAS) is a validated, subjective measure for assessing pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants indicate their pain level by marking a point along the line that corresponds to their current pain intensity. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant's mark, yielding a score between 0 and 100 mm. Higher scores represent greater pain intensity.
Visual Analog Scale (VAS) Score
时间窗: Every 4 hours for 24 hours following the procedure
The Visual Analog Scale (VAS) is a validated, subjective measure for assessing pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants indicate their pain level by marking a point along the line that corresponds to their current pain intensity. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant's mark, yielding a score between 0 and 100 mm. Higher scores represent greater pain intensity.
次要结局
- Analgesic Use by Category and Total Quantity (Non-Opiates) or Morphine Equivalents (Opiates) - Pre- and Post-Intervention(up to 6 months)