Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial (EFOPaKR-01)
Recruitment status was: Recruiting
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.
|Rheumatoid Arthritis||Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA) Dietary Supplement: Capsules (Placebo)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial|
- Pain Levels [ Time Frame: 10 weeks ]Pain assessment of patients will be measured using visual analog scale (VAS) score.
- Analgetics use [ Time Frame: 10 weeks ]All analgetics drugs used by patient will be noted
- Inflammatory Markers [ Time Frame: Day 1 ]Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6).
- Fatty Acids Composition [ Time Frame: Day 1 ]ω3 incorporation into blood cell membranes(RBC)
- Cortisol [ Time Frame: Day 1 ]Cortisol levels in blood test.
- ACTH [ Time Frame: Day 1 ]ACTH levels in blood test.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Fish oil group
Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)
Patient will receive Fish Oil capsules (EPAX 6000 EE) .
Treatment: 5 capsules per day
Other Name: Caps.Omeguard Triomar 1000 mg SGC
Placebo Comparator: Control group
Dietary Supplement: Capsules (Placebo)
Patient will receive capsules which not contain fish oil.
Treatment: 5 capsules per day
Post surgical pain level and analgesics use
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274910
|Contact: Pierre Singer, Professor, MDemail@example.com|
|Contact: Milana Grinev, RN, Study Coordinatorfirstname.lastname@example.org|
|Rabin Medical Center, Campus Beilinson||Recruiting|
|Petah Tikva, Israel, 49100|
|Contact: Pierre Singer, Professor ,MD 972-39376521 email@example.com|
|Contact: Milana Grinev, RN, Study Coordinator 972-39376521 firstname.lastname@example.org|
|Sub-Investigator: Sigal Frishman, RD|
|Principal Investigator:||Pierre Singer, Professor, MD||ICU dep't, Rabin MC,Petah Tikva, Israel|
|Study Director:||Milana Grinev, RN, Study Coordinator||ICU dep't, Rabin MC, Petah Tikva, Israel|