Effects of Intravenous Lidocaine on Endometriosis Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale (VAS)
研究概览
简要总结
We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved intravenous lidocaine to treat irregular heart beats, but the FDA has not approved intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used for more than 25 years to treat different acute and chronic pain conditions but has not yet been studied for endometriosis pain.
This is a cross-over trial over two months where one month you will receive the active medication (lidocaine) and one month you will receive the active placebo (diphenhydramine, commonly known as benadryl). We will compare the effect on pain from endometriosis of lidocaine to active placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IV Lidocaine
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
干预措施: IV Lidocaine (Drug)
IV diphenhydramine
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
干预措施: IV diphenhydramine (Drug)
结局指标
主要结局
Change in Visual Analogue Scale (VAS)
时间窗: 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)
Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain). Change scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete: (15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)
次要结局
- Change in Short Form McGill Pain Questionnaire 2(30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion))
- Change in Brief Pain Inventory (BPI): Pain on Average(1 day, 1 week, and 1 month post-treatment from BL (pre-infusion))
- Change in Hospital Anxiety and Depression Scale (HADS)(1 day, 1 week, and 1 month post-treatment from BL (pre-infusion))
研究者
Antje Barreveld, MD
MD
Brigham and Women's Hospital