Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain : A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6 months) at 3 months after first time of infusion
详细描述
Peripheral nerve injury may give rise to severe and long-lasting types of pains which are often resistant to treatment such as opioid, tricyclic antidepressant or anticonvulsant. Lidocaine infusion has been the one of intractable neuropathic pain treatment . My hypothesis the serial lidocaine infusion can adequate pain control and can prevent chronic pain (central sensitisation). Therefore, we designed this prospective, randomised, double-blind, controlled study to evaluate the efficacy of serial lidocaine infusion in peripheral neuropathic pain compared with placebo in long term outcome (at 3 month).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Peripheral neuropathic pain from peripheral nerve injury within 6 months after injury
- •Well understand to Thai language in writing or listening
排除标准
- •Underlying Heart disease or Arrhythmia
- •Allergy to lidocaine, Gabapentin, Carbamazepine, tramadol
- •History of epilepsy
- •History of lidocaine used
- •Underlying Psychiatric disease
- •History of drug abuse
- •Pregnancy and nursing
研究组 & 干预措施
Placebo group
Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times
干预措施: Placebo (Drug)
Lidocaine group
Lidocaine 3mg/kg in Normal Saline to 50 ml intravenous infusion in 1 hour once a week 4 times
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain intensity
时间窗: at 3 months after serial lidocaine infusion
Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable.
次要结局
- Quality of life using Utility score(at 3 month after serial lidocaine infusion)