A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Difference of Pain Scores on the Visual Analog Scale
研究概览
简要总结
The purpose of this study is to investigate adequate pain treatment for patients after cesarean. In this study oral opioids were compared to intravenous opioids as they are supposed to provide superior pain control.
详细描述
Pain management after cesarean is an important topic for women. Pain during and after surgery is their greatest concern.
After surgery quick mobilization is important to take care of the newborn. When using a patient controlled analgesia (PCA) device mobilization is limited and women can not meet their expectations to take care of the newborn. Oral analgesia in comparison offers superior patient satisfaction.
This trial was conducted to investigate the effectiveness of both treatment options and improve patients pain management and overall content after cesarean.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •cesarean in spinal anesthesia,
- •no history of opioid or metamizol treatment
- •written consent
- •ability to use a Patient-controlled analgesia device
排除标准
- •cesarean in general anaesthesia
- •use of peridural catheter for pre-, peri- or post cesarean analgesia
- •additional post cesarean metamizol use
- •allergy/hypersensitivity to morphine, oxycodon, acetaminophen or ibuprofen
- •chronic use of general anaesthesia
- •history of known pain syndrome
研究组 & 干预措施
Oxycodon
干预措施: Oral Oxycodon (Drug)
Patient controlled analgesia (PCA) device with Pritramid
干预措施: Piritramid (Drug)
结局指标
主要结局
Difference of Pain Scores on the Visual Analog Scale
时间窗: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.
The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline. For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain. Single value were calculated (averaged).
次要结局
- Mobilisation(6 month)
- Subgroups(6 month)
- Side Effects(6 month)
- Costs(6 month)
研究者
Max Dieterich
Dr. Max Dieterich
University of Rostock