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临床试验/NCT03288428
NCT03288428已完成4 期

Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
1
主要终点
numerical rating scale

研究概览

简要总结

to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy.

详细描述

To compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy, by using patient controlled analgesia postoperatively, a randomized, double blind clinical trial. Patients undergoing elective Laparoscopic myomectomy are randomly divided into two groups: nalbuphine and morphine groups. All patients are under general anesthesia with routine methods. The nalbuphine group receive postoperative patient controlled analgesia using nalbuphine 30mg/120ml, while the morphine group receive postoperative patient controlled analgesia using morphine 60mg/120ml. Perioperative parameters are to be collected to compare the two groups.

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, Care Provider, Investigator)

盲法说明

double blind

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective Laparoscopic myomectomy patients 24hr post-operative patient controlled analgesia analgesia no mild or severe liver or renal disfunction

排除标准

  • can't understand patient controlled analgesia device refuse trial

研究组 & 干预措施

nalbuphine

Experimental

using nalbuphine for patient controlled analgesia

干预措施: Nalbuphine (Drug)

morphine

Active Comparator

using morphine for patient controlled analgesia

干预措施: Morphine (Drug)

结局指标

主要结局

numerical rating scale

时间窗: 24 hr post-operatively

1-10

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yan Zhou, MD

MD

Peking University First Hospital

研究点 (1)

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