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临床试验/NCT01274910
NCT01274910Unknown不适用

Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial

Rabin Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年1月最近更新:
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适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Pain Levels
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single-center, prospective, randomized, double blind, placebo control study. The aim of this study is to assess the effect of fish oil capsules on pain intensity and postoperative analgesics consumption in patients after knee replacement surgery.

The study population will be adult are referred for knee replacement surgery due to osteoarthritis of the knee.

详细描述

Primary outcome:

Post surgical pain level and analgesics use

Secondary outcomes:

  1. Pain levels and analgesic use at six weeks and 3 months after surgery
  2. ω3 incorporation into blood cell membranes(RBC)
  3. Stress and inflammation markers
  4. Rates of postoperative complications

Study Procedure :

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)

入排标准

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

入选标准

  • •Patients are referred for knee replacement surgery due to osteoarthritis of the knee

排除标准

  • •Use of steroids, NSAIDs two weeks before surgery, antidepression drugs, antiepileptic drugs, coumadin
  • •Diabetic neuropathy
  • •Herpes-zoster/ post-herpetic neuralgia
  • •n-3 supplements use

结局指标

主要结局

Pain Levels

时间窗: 10 weeks

Pain assessment of patients will be measured using visual analog scale (VAS) score.

Analgetics use

时间窗: 10 weeks

All analgetics drugs used by patient will be noted

次要结局

  • Inflammatory Markers(Day 1)
  • Fatty Acids Composition(Day 1)
  • Cortisol(Day 1)
  • ACTH(Day 1)

研究者

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

Pierre singer

Professor, MD

Rabin Medical Center

研究点 (2)

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