NCT00927979已完成3 期
Phase 3 Prospective, Randomized, Controlled and Double-blinded Second Trial on Pain Relief by Continuous Intra-peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia, During Gynecological Laparoscopic Surgery
Carmel Medical Center0 个研究点目标入组 40 人开始时间: 2009年6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
- 主要终点
- Visual Analog Score (VAS)
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 gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.
详细描述
Outcome Measures :
- VAS score
- Use of analgesics during operation and postoperative period
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective gynecological laparoscopic surgery including unilateral or bilateral salpingo-oophorectomy or ovarian cystectomy
- •Patient not participating in other medical study at present or during the last 30 days
- •Patient is capable of reading, understanding and signing on an informed consent
- •Age 18 years and above
- •ASA physical status grade 1-2
排除标准
- •Allergy to ropivacaine or other local anesthetics or other medications listed in the protocol
- •Acute pelvic inflammatory disease
- •Coumadin or aspirin treatment
- •Significant arrythmias
- •Analgesic treatment for chronic pain
研究组 & 干预措施
Ropivacaine
Experimental
干预措施: 10 mLRopivacaine 1% (Drug)
Ropivacaine
Experimental
干预措施: 10 mL Ropivacaine 1% (Drug)
Water for injection
Placebo Comparator
干预措施: Water for injection (Drug)
结局指标
主要结局
Visual Analog Score (VAS)
时间窗: 24 hours
次要结局
- Use of Analgesics(24 hours)
研究者
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