NCT00768456已完成4 期
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie
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
- 48
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy.
The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, 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
- •eligible for elective vaginal hysterectomy
- •able to speak and understand Danish
- •able to give informed consent
排除标准
- •alcohol or medical abuse
- •allergies to local anesthetics
- •age < 18 yrs.
- •intolerance to opioids
研究组 & 干预措施
1
Active Comparator
Local infiltration with Ropivacaine
干预措施: Ropivacaine 0.5 % (Drug)
2
Placebo Comparator
Local infiltration with Placebo (NaCl)
干预措施: Isotonic NaCl (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 32 h
次要结局
- PONV(32 h)
研究者
研究点 (1)
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