NCT00433316已完成3 期
Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery
Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological laparoscopic surgery.
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, Care Provider, Investigator)
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
- •Elective gynecologic laparoscopic surgery including unilateral or bilateral salpingo-oopherectomy or ovarian cystectomy.
- •The patient is not participating in other medical study at present or in the last 30 days.
- •The patient signed on an informed consent.
- •Age 18 years and above.
- •ASA (American Society of Anesthesiologists) physical status grade 1- 2.
排除标准
- •Allergy to Ropivacaine, other local anesthetics or other medications listed in the protocol.
- •The patient is participating in other medical experiment at present or in the last 30 days.
- •Acute Pelvic Inflammatory Disease.
- •Coumadin or Aspirin treatment.
- •ASA physical status grade 3-
- •Age < 18 years.
- •Significant arrythmias
- •Analgesic treatment for chronic pain
研究组 & 干预措施
study
Experimental
Receiving 10ml of 1% ropivacaine
干预措施: ropivacaine (Drug)
Control
Placebo Comparator
Receiving 10ml of saline
干预措施: Aeroneb Pro Nezulizer, Aerogen, Ireland (Device)
结局指标
主要结局
VAS score
时间窗: early post-operative
次要结局
未报告次要终点
研究者
研究点 (1)
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