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临床试验/NCT00724685
NCT00724685终止4 期

Interest of Continuous Ropivacaine Administration Through an Elastomeric Pump (Pain Buster ) for the Surgery of Latissimus Dorsi and Serratus Micro Anastomotic Flaps

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

干预措施: Placebo (Drug)

Active

Experimental

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

研究者

申办方类型
Other

研究点 (1)

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