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临床试验/NCT04111406
NCT04111406终止不适用

Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice

Mahidol University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年1月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
29
试验地点
1
主要终点
Overall incidence of inadequate epidural analgesia

研究概览

简要总结

Epidural analgesia is the recommended analgesic technique in patients having surgery with severe postoperative pain such as thoracic and upper abdominal surgery. However, from the previous study, the incidence of inadequate pain control in patients receiving epidural analgesia is very high 48.6% in our hospital.

详细描述

A high incidence of inadequate epidural analgesia may result from variety of epidural techniques and epidural drug administrations. The protocol based practice has been developed from acute pain service which founded for more than 10 years. By using protocol based practice, the investigators believed that the incidence of inadequate epidural analgesia will be less compared with the current practice.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • All patients age ≥ 18 years old undergo surgery with epidural catheter insertion at Siriraj hospital.

排除标准

  • Coagulopathy
  • Allergy to study drugs: local anesthetics and opioids
  • History of chronic pain

研究组 & 干预措施

Current practice

Other

Epidural insertion and epidural drug administration depend on anesthetist in charge

干预措施: Current practice (Drug)

Protocol based

Experimental

Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based

干预措施: Protocol based (Drug)

结局指标

主要结局

Overall incidence of inadequate epidural analgesia

时间窗: 72 hours

To compare the overall incidence of inadequate epidural analgesia until considered removal between protocol-based and current practice by using the definition of inadequate analgesia as pain score of 4 or more out of 10 on numeric rating scale (0; no pain, 10; worst imaginable pain) at rest.

次要结局

  • Side effects(72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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