Interest of Continuous Ropivacaine Administration Through an Elastomeric Pump (Pain Buster ) for the Surgery of Latissimus Dorsi and Serratus Micro Anastomotic Flaps
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
Continuous bupivacaine administration through an elastomeric pump (Pain Buster) has been found effective for post operative analgesia in a large range of surgery. Ropivacaine is a less toxic drug, never tested in the surgery of latissimus dorsi and serratus micro anastomotic flaps (from the investigators knowledge). The aim of the study is to evaluate the usefulness of this drug and device for post operative analgesia, associated with patient controlled analgesia with morphine. For this purpose a controlled randomized double blind trial against placebo (saline) is performed, enrolling 40 (20x2) patients during 3 years, in order to measure total morphine consumption during the first 48 post operative hours and to evaluate analgesia and sides effects of morphine in each group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •operated for latissimus dorsi and serratus micro anastomotic flaps.
- •18 to 75 years old
- •hospitalized in Nantes CHU Burns ICU
- •giving their written informed consent
- •with healthcare protection
排除标准
- •declining the study
- •with known sides effects with morphine and local anesthetics
- •with known allergy or other reaction with used drugs
- •with disease incompatible with anaesthetic procedure
- •under law protection
- •taking antiepileptic or antidepressant drugs
- •pregnant (not any gender criteria)
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Active
干预措施: Naropeine (Ropivacaine) (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: H 48
次要结局
未报告次要终点
