Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
试验速览
- 阶段
- 不适用
- 发起方
- NHS Fife
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time in hours to passage of first stool post Caesarean Section.
研究概览
简要总结
Constipation following elective Caesarean sections (CS) is a common problem experienced by up to 50% of patients (1). The causes for this are multifactorial and include manipulation of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic techniques. To try to alleviate the problem of postoperative constipation, some anaesthetists prescribe postoperative lactulose in addition to postoperative analgesia, although no data exists that shows whether this has any beneficial effect on postoperative constipation.
- Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4).
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS
排除标准
- •Unable to give informed consent
- •A basic level of literacy sufficient to complete postoperative form.
- •History of constipation
- •Regular opiate use
- •Previous bowel surgery or bowel adhesions
- •Lactose intolerant
- •Any patient unable to have spinal Anaesthesia
- •Allergies/intolerant to bupivacaine, diamorphine, diclofenac, cocodamol, lactulose
- •Patients receiving injury to bowel intraoperatively
- •Patients receiving additional opiates perioperatively
研究组 & 干预措施
Lactulose group
Group receives 48 hours of lactulose post Caesarean section.
干预措施: Lactulose (Drug)
结局指标
主要结局
Time in hours to passage of first stool post Caesarean Section.
时间窗: First 5 days post Caesarean section.
Time (hours) to first bowel motion post elective LSCS betwwen Lactulose and non-Lactulose groups.
次要结局
- Frequency of abdominal pain between lactulose and non-lactulose groups.(First 5 days post Caesarean section.)
- Frequency of nausea and vomiting between lactulose and non-lactulose groups(First 5 days post-Caesarean)