Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pain relief
研究概览
简要总结
This prospective observational study evaluates the effectiveness and safety of intravenous lacosamide as a rescue treatment for acute pain in patients presenting to the emergency department with trigeminal neuralgia
详细描述
This study is a prospective observational investigation evaluating the effectiveness and safety of intravenous lacosamide as a rescue treatment for acute pain exacerbations in trigeminal neuralgia. The trial will be conducted at Hospital Universitari de Bellvitge over a two-year period, enrolling approximately 20 patients who present to the emergency department with acute TN pain and receive intravenous lacosamide based on the treating physician's discretion.
Trigeminal neuralgia is characterized by severe, paroxysmal facial pain, often resistant to conventional therapies. While sodium channel blockers such as carbamazepine and oxcarbazepine are first-line treatments, many patients experience refractory pain or unacceptable side effects. Evidence supporting intravenous options for acute exacerbations remains limited, with studies suggesting potential benefits of phenytoin, lidocaine, and lacosamide. Lacosamide, a voltage-gated sodium channel modulator with a slow inactivation mechanism, has demonstrated efficacy in neuropathic pain and retrospective analyses of TN cases. However, no prospective studies have systematically evaluated its impact in the acute setting.
Data collection will include demographic and clinical variables, TN characteristics, prior treatments, lacosamide infusion parameters, and concurrent medication use. Pain response will be assessed using an 11-point Numerical Pain Rating Scale (NPRS) at baseline, 2 hours post-infusion, at ED discharge, and at 24 hours and 7 days. Additional outcomes include changes in attack frequency, interference with daily activities (Brief Pain Inventory-Facial), patient satisfaction (PGIC), duration of pain relief, and adverse events at multiple time points.
Lacosamide will be administered intravenously per standard clinical practice, with continuous hemodynamic monitoring during and after infusion. Patients will be followed in the ED for at least 2 hours, with structured telephone follow-ups at 24 hours and 7 days post-infusion.
This study aims to generate real-world data on the effectiveness of intravenous lacosamide in acute TN exacerbations. Given the lack of high-quality evidence for emergency pain management in TN, findings may inform future controlled trials and refine clinical recommendations.
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
- •All patients diagnosed with trigeminal neuralgia who present to the emergency department of Hospital de Bellvitge for an acute pain exacerbation and are prescribed intravenous lacosamide as symptomatic pain treatment, according to the treating physician's discretion, will be considered for inclusion.
- •Inclusion Criteria:
- •Diagnosis of classical or idiopathic trigeminal neuralgia according to the criteria of the International Classification of Headache Disorders (ICHD-3).
- •Age over 18 years.
- •Signed informed consent.
排除标准
- •Contraindication for treatment with lacosamide (previous hypersensitivity reaction, known atrioventricular block).
- •Mental or psychiatric illness that interferes with the ability to understand and sign the informed consent.
- •Language barrier.
- •Lack of cooperation.
结局指标
主要结局
Pain relief
时间窗: 2 hours post-infusion
Measured by the Numerical Pain Rating Scale (NPRS), which ranges from 0 (no pain) to 10 (worst imaginable pain). A decrease of ≥50% from baseline indicates improvement in pain intensity.
Adverse effects
时间窗: Through study completion, an average of 1 week
Incidence of adverse effects
次要结局
- Sustained pain relief(Through study completion, an average of 1 week)
- Impact on daily activities(After 7 days)
- Patient Global Impression of Change(Through study completion, an average of 1 week)
研究者
Albert Muñoz Vendrell
Principal Investigator
Hospital Universitari de Bellvitge