Postoperative Pain Management of Caesarean Section: a Prospective, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Postpartum pain intensity
研究概览
简要总结
Caesarean section is one of the most frequent surgeries causing severe postoperative pain. Poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. Moreover, it had been demonstrated that the intensity of postpartum pain is associated with depression. It is imperative to find out appropriate methods of postpartum pain alleviation. Currently, a lot of analgesic drugs and methods have been developed and used in clinical practice, such as patient-controlled analgesia, extended-release analgesics and multimodal analgesia. This prospective cohort study is aimed to investigate the outcome of each postoperative analgesic method used in caesarean section.
详细描述
This is a prospective, observational, cohort study. Patients undergoing elective caesarean section will be invited to the study. The written informed consent will be obtained prior to participation. After getting the written informed consent, data will be collected from medical records, questionnaires, patient diaries, visit records and telephone visit records. Through telephone visits, postpartum depression scale and postpartum chronic pain will be evaluated six weeks and three months after delivery. Demographic data, consumption of analgesics, analgesic methods, intensity of postoperative pain, complications, recovery time, score of depression scale will all be summarized. Numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Planing to undergo caesarean section with spinal anesthesia.
- •Scheduled to undergo cesarean section between 37 and 40 weeks of gestation.
- •American Society of Anesthesiology Physical Class 1-
- •Planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of NALDEBAIN.
排除标准
- •Not willing to provide informed consent.
- •Unable to receive opioids or NSAIDs due to contraindication.
- •Long-term use of opioids or drug abuse.
- •Suffering from chronic pain disease.
- •Having medical history of mental illnesses.
- •Diagnosed with Pre-eclampsia or eclampsia.
- •Diagnosed with gestational diabetes.
- •Unsuitable for participation judged by investigator.
研究组 & 干预措施
IV-PCA + NALDEBAIN group
Patients treated with the combination of IV-PCA and intramuscular injection of dinalbuphine sebacate will be allocated to IV-PCA + NALDEBAIN group.
干预措施: Intravenous patient-control analgesia (Drug)
IV-PCA + NALDEBAIN group
Patients treated with the combination of IV-PCA and intramuscular injection of dinalbuphine sebacate will be allocated to IV-PCA + NALDEBAIN group.
干预措施: Dinalbuphine sebacate (Drug)
IV-PCA group
Patients receiving intravenous patient-controlled analgesia (IV-PCA) will be allocated to IV-PCA group.
干预措施: Intravenous patient-control analgesia (Drug)
结局指标
主要结局
Postpartum pain intensity
时间窗: Within 5 days after delivery
Pain intensity is assessed by numerical rating scale (NRS) at least twice daily during hospital stay after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). The area under the curve of NRS are calculated.
次要结局
- Consumption of analgesics(Within 5 days after delivery)
- Breastfeeding(Up to 5 days after delivery)
- Satisfaction assessed by a four-point scale(6 weeks after delivery)
- Ambulation(Up to 5 days after delivery)
- Incidence of complications(Up to 5 days after delivery)
- Gastrointestinal function recovery(Up to 5 days after delivery)
- Postnatal Depression assessment(At baseline, 6 weeks and 3 months after delivery)
- Chronic pain intensity(6 weeks and 3 months after delivery)
研究者
Chi-Hsu Wang
Principal Investigator
Mackay Memorial Hospital