The Effect of Levetiracetam on the Postmastectomy Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Pain relief
研究概览
简要总结
The aim of this study is determine whether or not the antiepileptic drug Levetiracetam is an effective treatment of the postmastectomy pain syndrome.
详细描述
This study is a randomised, placebocontrolled, doubleblind study on the effect of the antiepileptic drug, levetiracetam, in patients suffering from PMPS. The treatment periods are 1 month each and the periods are separated by a 1-week washout period. The daily dose of levetiracetam is increased over a 2-week period to 3.000 mg/day. The primary effect variable is pain relief by the use of numeric rating scale. Secondary parameters are daily registration of pain performed by the patients during the treatment periods and the amount of escape medicine used (paracetamol and tramadol). Sensory testing is performed at baseline and after each treatment period.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptoms characteristic for postmastectomy pain syndrome with a duration of more than 3 months and at least 6 months after the operation.
- •Neuropathic pain diagnose confirmed by abnormities in the neurological investigation and/or psychophysical sensory testing
- •Average (1 week) pain score minimum 4 on a 11 points numerical rating scale for total pain.
- •Pain present minimum 4 out of 7 days.
- •Fertile women must use anticonception.
排除标准
- •Verified og suspected other reason than mastectomy/lumpectomy for the pain.
- •Known allergic effects to levetiracetam.
- •Known sideeffects to treatment with levetiracetam.
- •Pregnancy or breast-feeding.
- •Severe disease (terminal cancer, heart failure, kidney insufficiency, severe respiratory problems)
- •Compliance problems
结局指标
主要结局
Pain relief
时间窗: After 1 month treatment
次要结局
- Pain intensity measured daily on numeric rating scales(During treatment periods)