Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain Levels
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:
- Pain levels and analgesic use at six weeks and 3 months after surgery
- ω3 incorporation into blood cell membranes(RBC)
- Stress and inflammation markers
- 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
研究组 & 干预措施
Fish oil group
Treatment Group.
干预措施: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA) (Dietary Supplement)
Control group
Placebo group
干预措施: Capsules (Placebo) (Dietary Supplement)
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
Pierre singer
Professor, MD
Rabin Medical Center