NCT01025102已完成3 期
Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery
Bent Gymoese Jorgensen1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2010年1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
- 26
- 试验地点
- 1
- 主要终点
- Time to experience of moderate to severe postoperative pain
研究概览
简要总结
The purpose of this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.
详细描述
The purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Age 18-80
- •Shoulder surgery performed under interscalene block and general anesthesia
排除标准
- •Contraindication of interscalene block
- •Severe chronic obstructive lung disease
- •Non-cooperative patient
- •Intolerance to opioids
- •Pregnancy
- •Rheumatoid arthritis and diabetes with peripheral polyneuropathy
- •Chronic pain or daily opioid intake
研究组 & 干预措施
Naropin 0.1%
Experimental
干预措施: Naropin 0.1% cum sufentanil (Drug)
结局指标
主要结局
Time to experience of moderate to severe postoperative pain
时间窗: On day of surgery and 1., 2. and 3. postop. day
次要结局
- Side effects(On day of surgery and 1., 2. and. 3. postop. day)
研究者
Bent Gymoese Jorgensen
MD
Frederiksberg University Hospital
研究点 (1)
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