Postoperative Pain Management of Therapeutic Surgery: a Prospective, Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 634
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity (numerical rating scale)
研究概览
简要总结
Poor management of post-operative acute pain can contribute to medical complications including pneumonia, deep vein thrombosis, infection and delayed healing, as well as the development of chronic. In contrast, appropriate pain control is capable of reducing the postoperative complications, preventing the development of chronic pain, and improving the quality of life. The workloads of medical staffs and health care cost are subsequently decreased. Recently, a lot of analgesic methods have been developed and used in clinical practice, such as patient-controlled analgesia, ultrasound-guided long-term analgesia and multimodal analgesia. This study is aimed to investigate the effect of dinalbuphine sebacate, a long-acting analgesic, in postoperative pain management. This real world data can serve as a reference toward high health care quality.
详细描述
This is a prospective, observational, cohort study. Patients undergoing elective surgery will be invited to the study. The written informed consent will be obtained prior to participation. Demographic data, underlying condition, surgical procedures, consumption of anesthetics and analgesics, analgesic methods, postoperative complications, pain intensity and life quality will be collected from medical history and by questionnaires.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Needing pain management after elective surgery.
- •American Society of Anesthesiology Physical Class (ASA) between 1 and 3.
排除标准
- •Allergic to anesthetics, opioids, or medicine used during study period.
- •Severe comorbidity, such as cardiopulmonary disease and strock.
- •Abuse or long-term use of opioids.
- •Pregnant or breastfeeding.
- •Judged to be unsuitable subjects by investigator.
结局指标
主要结局
Postoperative pain intensity (numerical rating scale)
时间窗: From Day 0 to Day 5
Numerical rating scale (NRS) is used to assess pain intensity from surgical day (Day 0) to five days after surgery (Day 5). NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain).
次要结局
- Patient satisfaction(Within 5 days after surgery)
- Consumption of anesthetics(From Day 0 to Day 5)
- Adverse events(From Day 0 to Day 5)
- EQ-5D-5L score(Within 16 weeks after surgery)
- Consumption of analgesics(From Day 0 to Day 5)
研究者
Kee-Ming Man
Director, Department of Anesthesiology, China Medical University Hsinchu Hospital
China Medical University Hospital