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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 : Enrolled patient will be randomly divided into a control group and intеrvention group during preoperative clinic visit. Each patient will receive total 150 capsules (5 capsules per day) accordingly to randomized group. Patients in treatment group will receive Fish Oil capsules. Patients in control group will receive placebo capsules.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)
* Dietary Supplement: Capsules (Placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are referred for knee replacement surgery due to osteoarthritis of the knee Exclusion Criteria: Use of steroids, NSAIDs two weeks before surgery, antidepression drugs, antiepileptic drugs, coumadin Diabetic neuropathy Herpes-zoster/ post-herpetic neuralgia n-3 supplements use

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish oil group<br>Treatment Group. | Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)<br>* Patient will receive Fish Oil capsules (EPAX 6000 EE) . Treatment: 5 capsules per day<br>* Other names: Caps.Omeguard Triomar 1000 mg SGC;|
| Placebo Comparator: Control group<br>Placebo group | Dietary Supplement: Capsules (Placebo)<br>* Patient will receive capsules which not contain fish oil. Treatment: 5 capsules per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Levels | Pain assessment of patients will be measured using visual analog scale (VAS) score. | 10 weeks | 
| Analgetics use | All analgetics drugs used by patient will be noted | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Markers | Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6). | Day 1 | 
| Fatty Acids Composition | ω3 incorporation into blood cell membranes(RBC) | Day 1 | 
| Cortisol | Cortisol levels in blood test. | Day 1 | 
| ACTH | ACTH levels in blood test. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish Oil, Knee, Analgetics