NCT02597257Unknown2 期
Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain: Randomized, Controlled, Comparative Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 11-point Numeric Rating Scale
研究概览
简要总结
The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.
详细描述
The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •postherpetic neuralgia, diabetic polyneuropathy, peripheral neuropathy
- •NRS score > 4
- •stable oral medication during the 1 month trial period
- •volunteers with informed consent
排除标准
- •pregnancy, breastfeeding, possibility of pregnancy
- •pain from causes other than upper 3 indications
- •hypersensitivity to lidocaine or other local anesthetics
- •important disease of heart, kidney, liver or incurable disease that may affect the assessment of adverse effects, or may interfere with the completion of study
- •severe conduction block
- •history of other interventions that may affect the study
- •Enrollment in other clinical trials within 30 days
- •otherwise not suitable to study
研究组 & 干预措施
Normal Saline
Placebo Comparator
- normal saline
- total 250 ml
- once a week
- 4 times
干预措施: Normal saline (Drug)
Lidocaine HCl
Active Comparator
- lidocaine 3 mg/kg mixed in normal saline
- total 250 ml
- once a week
- 4 times
干预措施: Lidocaine HCl (Drug)
结局指标
主要结局
11-point Numeric Rating Scale
时间窗: 1 week after the end of intervention
Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain
次要结局
- Brief Pain Inventory Short Form(at the end of intervention and 4 weeks after the end of intervention)
- Shot Form McGill Pain Questionnaire(at the end of intervention and 4 weeks after the end of intervention)
- Patient Global Impression of Change(at the end of intervention and 4 weeks after the end of intervention)
- Number of patients with grade 3 through grade 5 adverse events that are related to study drug, graded according to NCI CTCAE version 4.0(through the study completion (7 weeks))
- 11-point Numeric Rating Scale(4 weeks after the end of intervention)
研究者
Yong Chul Kim
Professor
Seoul National University Hospital
研究点 (1)
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