The Efficacy and Safety of Oxycodone in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- NRS scores
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of hydrocodone in patient-controlled intravenous analgesia (PCIA) during gynecological laparoscopy, thus to explore suitable PCIA scheme to optimize postoperative pain management for patients undergoing gynecological laparoscopic surgeries.
详细描述
The controlled group will receive sulfentanil for PCIA, and the test group will receive hydrocodone for PCIA. NRS scores at 1, 6, 24 and 48 hours post-surgery will be recorded. The usage of rescue analgesics and adverse events will also be recorded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •selective laparoscopic hysterectomy
- •general anesthesia
- •ASA classification I - III
- •aged 18 - 65 years
排除标准
- •allergy to oxycodone or any other drugs will be used in the study
- •preoperative opioids medication
- •opioids abuse
- •hepatic or renal dysfunction
- •cardiovascular or pulmonary dysfunction
- •lack of full civil capacity or refuse to participate
结局指标
主要结局
NRS scores
时间窗: 6 hours after surgery
Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable.
次要结局
- NRS scores(30 days after surgery)
- rescue analgesics usage(from the end of surgery to the first usage (up to 48 hours post-surgery))
- PCIA pressing times(48 hours after surgery)
- anal exhaust time(from the end of surgery to the first anal exhaust (up to 48 hours post-surgery))
- adverse events(within 48 hours after surgery)
研究者
Siyuan Liu
Principal Investigator
Affiliated Hospital of Nantong University