Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of patients with opioid induced bowel dysfunction assessed with bowel function index
研究概览
简要总结
Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may further impair bowel function. The aim of the present study was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients undergoing caesarean section.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• elective caesarean section in spinal anaesthesia
- •normal full term single pregnancy
- •age 18 years or more
- •BMI 20 - 35 kg/m2
- •written informed consent obtained
排除标准
- •• not normal or full term pregnancy
- •age less than 18 years
- •allergy to study drugs
- •substance misuse other contraindication to used study drugs no informed consent
研究组 & 干预措施
Oxycodone-naloxone
Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section
干预措施: Caesarean section (Procedure)
Oxycodone
Oxycodone 10 mg prolonged release tablet twice a day after caesarean section
干预措施: Caesarean section (Procedure)
Oxycodone
Oxycodone 10 mg prolonged release tablet twice a day after caesarean section
干预措施: Oxycodone (Drug)
Oxycodone-naloxone
Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section
干预措施: oxycodone-naloxone (Drug)
结局指标
主要结局
Number of patients with opioid induced bowel dysfunction assessed with bowel function index
时间窗: time from the first drug intake up to three weeks postoperatively
次要结局
- Oxycodone concentrations in maternal plasma(time before the first drug intake to the day when patient leaves the hospital up to maximum of seven days postoperatively)
研究者
Merja Kokki
MD, PhD
Kuopio University Hospital