NCT01443325已完成3 期
Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- pain reduction with lidocaine patch
研究概览
简要总结
In the present placebo-controlled cross-over study the researchers intend to investigate analgesic and sensory effects of a lidocaine patch in patients with severe persistent inguinal post-herniorrhaphy pain.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males > 18 yrs
- •ASA (American Society´s of Anesthesiology´s classification) scores I-III, with severe Pain for more than six months and with average daily pain intensities (numerical rating scale [NRS] 0-10 points) during rest or during movement > 6.
排除标准
- •History of an allergic reaction or intolerance to amide local anesthetics or vehicle ingredients in the patches
- •Use of class I antiarrhythmic drugs (e.g., tocainide and mexiletine)
- •Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III
- •Inflamed or injured skin at the application site
- •Known severe hepatic disorder (Child-Pugh score > 6)
- •Known severe renal impairment, (creatinine clearance < 30 mL/min)
- •Signs of cognitive impairment or known drug or ethanol abuse during the last 2 years.
研究组 & 干预措施
lidocaine patch
Experimental
干预措施: lidocaine patch (Drug)
结局指标
主要结局
pain reduction with lidocaine patch
时间窗: assessed the last three days in each treatment period
次要结局
未报告次要终点
研究者
Joakim Bischoff
Research fellow, MD
Rigshospitalet, Denmark
研究点 (1)
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