Perioperative Regular Usage of Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain and Opioid Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of treatment-relate adverse events
研究概览
简要总结
To evaluate that perioperative regular usage of propacetamol to reduce post cesarean section uterine contraction pain and opioid consumption
详细描述
The most common method of pain control after cesarean section is intravenous patient-control analgesia (IVPCA) with morphine. Multimodal analgesia could improve the quality of perioperative pain control and reduceside effects of opioids. Previous researches marked that perioperative pain after cesarean section includes somatic wound pain and visceral uterine contraction pain.
According to Academy of Breastfeeding Medicine, propacetamol is a safe pain-killer for an expectant mother and almost free from breast milk after intravenous injection. This study is a prospective double-blind randomized-controlled trial to evaluate that propacetamol could reduce visceral uterine contraction pain after cesarean section. Post cesarean section women will divide into three groups:
- pain control with IVPCA for 2 days
- pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
- pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy more than 36 weeks which is expected to receive Caesarean section
- •Post Caesarean section woman, age greater than or equal to 20 years old
- •ASA physical status class 1 or 2
排除标准
- •ASA physical status class 3 or above
- •Less than 20 years old
- •Past caesarean section for longitudinal wounds
- •Undergone major abdominal surgery
- •Chronic pain
- •Allergic to morphine or Propacetamol
- •Liver dysfunction
- •Treatment with anticoagulant
- •Emergency operation
研究组 & 干预措施
propacetamol 1g
pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
干预措施: Propacetamol 1g (Drug)
propacetamol 1g
pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
干预措施: IVPCA (Drug)
propacetamol 2g
pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
干预措施: Propacetamol 2g (Drug)
propacetamol 2g
pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
干预措施: IVPCA (Drug)
IVPCA
pain control with IVPCA
干预措施: IVPCA (Drug)
结局指标
主要结局
Incidence of treatment-relate adverse events
时间窗: Two days after the cesarean section
the complications or side effects during intervention, such as nausea/vomiting, skin itching, GI discomfort, urinary retention, and respiratory depression
Change of pain assessed by NRS
时间窗: Every 8 hours from post-anesthesia care unit to 2 days after the cesarean section
Change of pain assessed by Numerical Rating Scale: respondent selects a whole number (0-10 integers) that best reflects the intensity of the pain
Opioid consumption
时间窗: Two days after the cesarean section
Comparison with the placebo group, the requirement of opoid
次要结局
- Satisfaction assessed by the NRS(Two days after the cesarean section)
研究者
Chien-Chung,Huang
attending physician, department of anesthesiology
Mackay Memorial Hospital