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临床试验/NCT00375362
NCT00375362Unknown不适用

The Analgesic Efficacy of Nitroglycerin Patches for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
pain scores

研究概览

简要总结

Patients who undergo general anestheesia for total knee arthroplasty pften have sever postoperative pain which hinders their rehabilitation. Nitroglycerin patches have been found to cause alleviation of pain especially when used in conjuction with morphine. Therefore we propose placement of a nitroglycerin patch after total kneee arthroplasty surgery and see how it affects pain scores or causes less nedd for morphine after surgery.

详细描述

Patients undergoing total knee arthroplasty will be randomized into two groups: control and placebo.

Eache patient will undergo total knee arthroplasty under general anesthesia. Both groups will get the same anesthetic protocal. At the end of surgery, before awakening patients will recieve either a nitroglycerin or placebo patch on their back. Both the participant and the investigator will be blinded to the group assisignment. At the end of surgery both groups will recieve morphine for postoperative pain. In the recovery room they will be given patient controlled analgesia with morphine. An investigator blinded to study assisignment will record pain scores, sedation scores, nauseau and vomiting. Patients will be given patient controlled analgesia for 24 hours and they will be followed for pain levels, morphine use, sedation and nauseau levels. The nitroderm or placebo patch will be removed after 24 hours.

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
Double

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy patients undergoing total knee arthroplasty

排除标准

  • Pshychiatric disorder
  • Allergy to nitroglycerin or morphine
  • Chronic renal failure
  • Migraine headaches
  • Hypotension

结局指标

主要结局

pain scores

morphine use

sedation score

nausea and vomiting

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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