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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.
Primary outcome:
Post surgical pain level and analgesics use
Secondary outcomes:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil group | Active Comparator | Treatment Group. |
|
| Control group | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPAX 6000 EE 1000mg (0.6 gr DHA+EPA) | Dietary Supplement | Patient will receive Fish Oil capsules (EPAX 6000 EE) . Treatment: 5 capsules per day |
|
| 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 |
| 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) |
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Inclusion Criteria:
Patients are referred for knee replacement surgery due to osteoarthritis of the knee
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Singer, Professor, MD | Contact | 972-3-9376521 | psinger@clalit.org.il | |
| Milana Grinev, RN, Study Coordinator | Contact | 972-3-9376521 | milang@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Singer, Professor, MD | ICU dep't, Rabin MC,Petah Tikva, Israel | Principal Investigator |
| Milana Grinev, RN, Study Coordinator | ICU dep't, Rabin MC, Petah Tikva, Israel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center, Campus Beilinson | Recruiting | Petah Tikva | Petah Tikva | 49100 | Israel |
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| Capsules (Placebo) | Dietary Supplement | Patient will receive capsules which not contain fish oil. Treatment: 5 capsules per day |
|
| Day 1 |
| Cortisol | Cortisol levels in blood test. | Day 1 |
| ACTH | ACTH levels in blood test. | Day 1 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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