Comparison of the Effects of Hydromorphone and Nalbuphine Patient Controlled Analgesia in Postoperative Pain After Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Incidence of pain after caesarean section
研究概览
简要总结
Cesarean section is an essential surgical procedure in obstetrics, which not only addresses dystocia and certain obstetric syndromes, ensuring the safety of the maternal participants, but also increases perinatal survival rates and can save the mother's life. However, the surgical trauma and uterine contractions resulting from cesarean delivery lead to severe pain, which can hinder the mother's postoperative recovery and negatively affect her mental health. Therefore, improving postoperative pain management and addressing issues such as depression and anxiety are crucial challenges in clinical practice today.
Patient-controlled intravenous analgesia (PCA) is widely used in postoperative pain management after cesarean section due to its ability to maintain the minimum effective drug concentration, minimal fluctuation in drug levels, ease of management, and no restriction on activity. However, research on the effects and adverse reactions of hydromorphone and nalbuphine for postoperative pain relief in cesarean section is limited.
In this study, the investigators aim to compare the effects of hydromorphone hydrochloride and nalbuphine in obstetric PCA and examine how various clinical factors influence pain outcomes and adverse reactions. Based on multivariate analysis, the investigators further aim to construct and validate a predictive model for poor analgesic outcomes. To develop more personalized strategies for postoperative pain management following cesarean section, more personalized guidance strategies for postoperative pain management following cesarean section.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age range from 20 to 50 years old;
- •ASA grades I to III;
- •Full term pregnancy and planned cesarean section with transverse incision in the lower segment of the uterus;
- •Pregnant women who are willing to participate in this study and sign informed consent forms.
排除标准
- •Have a history of dementia, mental illness, or any central nervous system disorder;
- •Pregnant women who are addicted to alcohol and drugs;
- •Difficulty in follow-up or poor patient compliance;
- •Has taken other investigational drugs or participated in other clinical trials in the three months prior to being selected for the study;
- •Serious complications occur during delivery;
- •Unable to cooperate with the research for any reason.
结局指标
主要结局
Incidence of pain after caesarean section
时间窗: 2024-12-05-2025-05-30
Assessment of chronic postoperative pain by Brief Pain Inventory from 0 to ten, The higher the score, the stronger the pain
Incidence of inadequate analgesia
时间窗: 2024-12-05-2025-05-30
Postoperative pain is represented by NRS score (0-10). The higher the NRS score, the more severe the pain. A NRS score of ≥ 4 is considered inadequate analgesia.
次要结局
- Adverse effects of postoperative analgesia(2024-12-05-2025-05-30)
- Usage of patient controlled analgesia (PCA)(2024-12-05-2025-05-30)
- Diclofenac sodium dosage(2024-12-05-2025-05-30)
- Patient satisfaction(2024-12-05-2025-05-30)
- Length of hospital stay(2024-12-05-2025-05-30)
研究者
Xianwei Zhang，MD
Professor
Huazhong University of Science and Technology