Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia
研究概览
简要总结
Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous manifestations. The objective of this study was to evaluate the effect of the combination of intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A prospective, randomized, double-blind, comparative study was conducted. All patient received 25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks. Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a verbal numerical scale.
详细描述
Amitriptyline was chosen in the present study because it is the most widely used antidepressant with proven analgesic efficacy for the treatment of a variety of chronic pain syndromes. Amitriptyline also promotes improvement of sleep, an effect observed in the present study.
Lidocaine has been widely applied by the intravenous route and patients with a variety of pain syndromes, including fibromyalgia, have reported pain relief with this technique.The dose of lidocaine employed by various investigators ranges from 1 to 5 mg/kg administered over a period of 30-60 min. The minimum effective dose is 1.5 mL/L, which is achieved with 2-5 mg/kg infused over 30-60 min. In these study, 240 mg lidocaine was administered, corresponding to about 3 mg/kg.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pain in the four quadrants of the body for at least 3 months
- •sleep disorders
- •subjective edema
- •depression
- •paresthesia.
排除标准
- •alterations in thyroid
- •rheumatological
- •renal and hepatic function
- •rheumatic, neuromuscular or psychiatric disease
- •infectious arthropathy
- •other pain syndromes
- •drug hypersensitivity
- •pregnancy
研究组 & 干预措施
Lidocaine
Patients received 240 mg lidocaine diluted in 125 mL 0.9% saline. The solutions were infused over a period of 1 h, once a week, for 4 weeks (T1, T2, T3 and T4).
干预措施: Lidocaine (Drug)
结局指标
主要结局
effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia
时间窗: 4 weeks
次要结局
- Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity(4 weeks)