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.
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 : 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Patient will receive Fish Oil capsules (EPAX 6000 EE) . Treatment: 5 capsules per day
Patient will receive capsules which not contain fish oil. Treatment: 5 capsules per day
Rabin Medical Center, Campus Beilinson
Petah Tikva, Petah Tikva, Israel
RECRUITINGPain Levels
Pain assessment of patients will be measured using visual analog scale (VAS) score.
Time frame: 10 weeks
Analgetics use
All analgetics drugs used by patient will be noted
Time frame: 10 weeks
Inflammatory Markers
Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6).
Time frame: Day 1
Fatty Acids Composition
ω3 incorporation into blood cell membranes(RBC)
Time frame: Day 1
Cortisol
Cortisol levels in blood test.
Time frame: Day 1
ACTH
ACTH levels in blood test.
Time frame: Day 1
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