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临床试验/NCT01917448
NCT01917448已完成4 期

Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-Blind Controlled Trial

Mahidol University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2014年2月最近更新:
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
36
试验地点
1
主要终点
Total post-operative morphine requirement.

研究概览

简要总结

One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain. Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour postoperative requirement comparing to control group.

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
Quadruple (Participant, Care Provider, Investigator, 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

  • ASA (American Society of Anesthesiologist) physical status I to III,
  • Undergoing elective video-assisted thoracoscopic surgery at Siriraj and Thammasart Hospitals
  • capable of using a patient-controlled analgesia (PCA) machine
  • understanding the numeric rating scale (NRS) score for pain assessment.

排除标准

  • history of allergy to the study drugs
  • bleeding disorder
  • infection of the back
  • refusing spinal anesthesia
  • history of cerebrovascular disease
  • using postoperative ventilator support were excluded

研究组 & 干预措施

Control

Sham Comparator

The skin will be injected with local anesthetic without spinal block

干预措施: control (Other)

Spinal morphine

Active Comparator

0.15 mg spinal morphine

干预措施: Morphine (Drug)

结局指标

主要结局

Total post-operative morphine requirement.

时间窗: 48 hours

次要结局

  • Pain after surgery(48 hour)

研究者

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

Sirilak Suksompong

Associate Professor

Mahidol University

研究点 (1)

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