The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks
研究概览
简要总结
Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the management of neuropathic pain in the short term - up to six hours.
详细描述
This study will examine the role of intravenous lidocaine in the relief of neuropathic pain over four weeks following infusion compared to an active placebo infusion of diphenhydramine(Benadryl) in normal saline. If we can show that intravenous lidocaine provides sustained benefit for up to one month, this will be a major advance in the management of individuals suffering from neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic neuropathic pain due to diabetes mellitus or herpes zoster and a score of 4/10 or greater on the DN4 questionnaire.
- •Moderate to severe pain as defined by screening average pain intensity of 5 or greater on a 0-10 numerical rating scale.
- •Neuropathic pain duration of at least 6 months.
排除标准
- •Presence of clinically significant cardiac disease.
- •Poorly controlled seizure disorder.
- •Significant psychiatric disorder.
- •History of allergy to lidocaine or any other amide local anesthetic
- •History of allergy to diphenhydramine.
- •Prior treatment with a local anesthetic infusion.
- •Neuropathic pain due to cancer or complex regional pain syndrome
- •Language barrier or cognitive impairment that would preclude understanding of the study and filling out of questionnaires
- •Lack of a driver to transport the patient to and from the pain clinic.
研究组 & 干预措施
Diphenhydramine(Benadryl)
干预措施: Diphenhydramine (Drug)
Lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks
时间窗: every 24 hours for four weeks post-infusion
次要结局
- Hospital Anxiety and Depression Scale(obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4)
- Patient Global Satisfaction with Treatment and Impression of Change(obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4)
- Modified Brief Pain Inventory(obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4)
- Quality of Life Health Outcome Instrument(obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4)
- Leeds Sleep Evaluation Questionnaire(obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4)
- Side Effects(obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4)