NCT00769054已完成4 期
Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, 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 during rest, coughing and ambulation
研究概览
简要总结
The purpose of this study is to compare systematic local infiltration with ropivacaine or placebo in patients undergoing repair of posterior vaginal wall prolapse.
The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.
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 repair of posterior vaginal wall prolapse
- •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 (Drug)
2
Placebo Comparator
Local Infiltration with Placebo
干预措施: Isotonic NaCl (Drug)
结局指标
主要结局
Postoperative Pain during rest, coughing and ambulation
时间窗: ½, 1, 2, 4, 8, 12 and 24 h postoperatively
次要结局
- Postoperative Nausea and Vomitus(½, 1, 2, 4, 8, 12 and 24 h postoperatively)
研究者
研究点 (1)
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