Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Total morphine consumption during first 24 hours postoperatively
研究概览
简要总结
A Prospective double-blinded randomized clinical trial to test the effect of transversus abdominis plane block on postoperative pain and opoid consumption after abdominal hysterectomy.
Two groups of each 24 patients. All patients are given general anesthesia. The patients are randomized to have a ultrasound guided bilateral transversus abdominis plane block with either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided with a PCA for self administration of morphine.
Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively as well as the total consumption of morphine after 24 hours.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Assigned to elective abdominal hysterectomy
- •Must be able to understand and speak danish
- •Must be able to give verbal and written consent
排除标准
- •Abuse of alcohol or medicin
- •Daily treatment with opoids or glucocorticoids
- •Allergy towards any kind of localanesthetic drug
- •Intolerance toward morphine
- •Psychiatric desease
- •Age below 18
结局指标
主要结局
Total morphine consumption during first 24 hours postoperatively
时间窗: At 24 hours postoperatively
次要结局
- Postoperative pain by visual analog scale at(Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively)
研究者
Billy B Kristensen
MD
Hvidovre University Hospital