Postoperative Analgesia and Antihyperalgesia of Tramadol and Acetaminophen Per Oral After Caesarean Section -A Randomised Controlled Trial in Female O-Desmethyl 1 Metabolizers Identified by the Respective Gene-
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- VAS-Score at leg rising
研究概览
简要总结
The aim of this study is to evaluate quality of patient-controlled peroral analgesia after cesarian section using the combination of tramadol and acetaminophen. Research hypothesis is that the combination reduces pain at leg rising more than tramadol alone.
详细描述
Caesarean section rate is growing in western countries (from 9% by 1980, to 12% by 1990 up to 22-24% in 2002)1.
Pain after Caesarean section involves 2 components, somatic pain from the wound and visceral pain from uterine contractions2. Different mechanisms underlie somatic and visceral pain transmission, at spinal and supraspinal levels, supporting different sensitivity to analgetics2. Pain at rest is usually well controlled by parenteral opioids, while pain induced by movements is less responsive to opioids, requesting higher doses with an increase of side effects3.
Beyond the concern of short term recovery, postoperative pain management has an impact on the risk of developing residual pain after surgery4. Following Caesarean section 18% of patients still suffer from pain 3 months after surgery. 12% still complain after 10 months and for 6% pain is a significant problem, interfering with quality of life and being present daily or almost daily5.
Central sensitization, clinically expressed as hyperalgesia and allodynia, not only contributes to postoperative pain perception, but also is associated with the presence of chronic pain state6.
Aside from tissue damage, the most striking risk factor for developing residual pain seems to be the level of immediate postoperative pain7.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 and 45 years
- •ASA-Status 1-2
- •BMI 19-29, that are scheduled for planned caesarean section and have given written informed consent
排除标准
- •Allergies or hypersensitivities to evaluated drugs
- •History of pain syndrome
- •Substance abuse
- •Preeclampsia or eclampsia
- •Deviation from standardised surgical procedure
- •Treatment with magnesium sulfate
- •Renal or hepatic impairment and deviations from the standardized anaesthetic treatment
结局指标
主要结局
VAS-Score at leg rising
时间窗: 4h, 8h, 24h 48h postoperatively
次要结局
- VAS-Score at rest, nausea, vomitus, sedation, general satisfaction(4h, 8,h, 24h, 48h postoperatively)
