NCT00978601已完成不适用
Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy.A Randomized Study.
Iakentro Fertility Centre2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2007年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- The main outcome measure is the Visual Analog Scale (VAS) score at 2 and 8 hours post surgery.
研究概览
简要总结
The purpose of this study is to evaluate a multimodal analgesic protocol used in minimally invasive surgery for myomectomies (laparoscopic myomectomy (LM) and laparoscopically assisted myomectomy (LAM)).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptomatic intramural and or subserous myomas
- •ASA score 1-2
- •Without contraindication to nonsteroidal anti-inflammatory agents
- •Patients have to be able to understand and follow medical instructions
- •They need to have satisfactory hygiene and accommodation conditions
- •They have to live not more than 2 hours away from the department
- •Easy telephone contact is required
排除标准
- •Ovarian disease
- •Previous medical treatment for ovarian suppression, pregnancy, abnormal Papanicolaou (Pap) test smear or hyperplasia (with or without atypia) in case of endometrial biopsy
结局指标
主要结局
The main outcome measure is the Visual Analog Scale (VAS) score at 2 and 8 hours post surgery.
时间窗: 2 and 8 hours post surgery.
次要结局
- hours of the bowel peristalsis return, hours of hospitalization, and number of days for the fully recuperate activity are also measured.(hours to few days after the intervention)
研究者
研究点 (2)
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