跳至主要内容
临床试验/NCT00873743
NCT00873743暂停不适用

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-

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年10月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Analgesia and Antihyperalgesia of Tramadol and... | 临床试验