NCT00370240已完成4 期
Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Comparing the frequencies of chronic breast pain 3 months after breast surgery evaluated by the Brief Pain Inventory in the two groups.
研究概览
简要总结
The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of ropivacaine) to prevent chronic pain after breast surgery for cancer.
详细描述
An estimated 20-65% of women treated with breast surgery for breast cancer experience chronic pain in the treated breast. Patients will be randomize between: infiltration with chlorhydrate of ropivacaine at the time of breast surgery for cancer versus placebo.Intra-operative analgesia will be standardized as well as peri-operative pain management.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients treated by conservative surgery with axillary node dissection or treated by mastectomy with or without axillary node dissection or sentinel lymph node biopsy.
- •ASA physical status 1, 2 or 3
- •With a minimum life expectancy of 2 years
- •Written informed consent
排除标准
- •Any previous cancer other than breast cancer
- •Allergies to local anesthesic and morphine
- •Reported history of drug
- •Pregnancy
- •Homolateral breast surgery during the last 3 years
- •Analgesic use pre-operatively
- •Renal, pulmonary or liver major dysfunction
- •Active malignant disease
- •Unable to follow the protocol for any reason
研究组 & 干预措施
Ropivacaïne
Experimental
干预措施: Chlorhydrate de Ropivacaine (Drug)
placebo
Placebo Comparator
干预措施: placebo (Other)
结局指标
主要结局
Comparing the frequencies of chronic breast pain 3 months after breast surgery evaluated by the Brief Pain Inventory in the two groups.
时间窗: 3 months after surgery
次要结局
- Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale(2 hours after surgery)
研究者
研究点 (1)
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