ZIH Study : Comparison of Oral Zaldiar (Combination of Paracetamol and Tramadol) With Intravenous Paracetamol and Tramadol for Postoperative Analgesia After Inguinal Hernia Repair
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- Acute Pain
研究概览
简要总结
Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).
详细描述
Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients incoming for inguinal hernia repair
排除标准
- •Preoperative abuse of analgesics
研究组 & 干预措施
Group Z
Postoperative Analgesia with Zaldiar
干预措施: Zaldiar (Drug)
Group PT
Postoperative Analgesia with Paracetamol-Tramadol
干预措施: Paracetamol-Tramadol (Drug)
结局指标
主要结局
Acute Pain
时间窗: In recovery room
Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS \> 4. The VAS use units on a scale.
次要结局
未报告次要终点
研究者
Eric DEFLANDRE, MD, PhD, FCCP
Eric DEFLANDRE, MD, FCCP
Astes