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临床试验/NCT00695045
NCT00695045已完成不适用

Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty

University College Hospital Galway0 个研究点目标入组 60 人开始时间: 2003年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
pain

研究概览

简要总结

This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.

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, 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

  • Patients for elective total knee arthroplasty

排除标准

  • No contraindication to spinal
  • No allergy to morphine, rescue analgesia or anti-emesis treatment.

研究组 & 干预措施

1

Experimental

patients in this group got 100mcg of intrathecal morphine.

干预措施: intra thecal morphine (Drug)

2

Experimental

patients in this group got 200 mcg intrathecal morphine

干预措施: intra thecal morphine (Drug)

3

Experimental

patients in this group given 300 mcg intrathecal morphine.

干预措施: intra thecal morphine (Drug)

结局指标

主要结局

pain

时间窗: 24 hours

次要结局

  • nausea and vomiting(24 hours)
  • pruritus(24 hours)
  • sedation(24 hours)

研究者

发起方
University College Hospital Galway
申办方类型
Other

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