NCT01625572已完成不适用
Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Pain in rest in the op-area
研究概览
简要总结
The purpose of this study is to compare the quality of a transversus abdominis plane blockade with an intravenous pain therapy with opioids. Due to the relatively low side effect profile and comparably few contraindications, this method offers a good option, to be a standard procedure or better alternative in the treatment of pain in surgery of the prostate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients at the age of 18 and above, who need an open prostatectomy
- •written consent exists
排除标准
- •American Society of Anaesthesiologists (ASA) classification > III
- •Allergy to local anaesthesia
- •Contraindications to one of the applied methods
- •previous surgery on the abdominal wall
- •chronic pain patients
- •Myasthenia gravis
- •alcohol dependence
- •increased intraocular pressure
- •lacking willingness to save and hand out data within the study
- •Participation in another trial according to the German Drug Law
- •accommodation in an institute due to an official or judicial order
结局指标
主要结局
Pain in rest in the op-area
时间窗: 3 days
Pain in rest in the op-area during the first 3 days
次要结局
- Contentment with the pain therapy at all(3 days)
- Tenesmuses of the bladder(3 days)
- Contentment of the Patient at all(3 days)
- Frequency of postoperative vomiting and nausea(3 days)
- Pain outside the op-area(3 days)
- Opioid consumption(3 days)
- Pain in motion in the op-area(3 days)
- Incidence of pruritus(3 days)
研究者
Jurgen Birnbaum
PD Dr. med.
Charite University, Berlin, Germany
研究点 (2)
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