Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial (EFOPaKR-01)
|ClinicalTrials.gov Identifier: NCT01274910|
Recruitment Status : Unknown
Verified February 2013 by Pierre singer, Rabin Medical Center.
Recruitment status was: Recruiting
First Posted : January 12, 2011
Last Update Posted : November 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA) Dietary Supplement: Capsules (Placebo)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||January 2014|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274910
|Contact: Pierre Singer, Professor, MDfirstname.lastname@example.org|
|Contact: Milana Grinev, RN, Study Coordinatoremail@example.com|
|Rabin Medical Center, Campus Beilinson||Recruiting|
|Petah Tikva, Israel, 49100|
|Contact: Pierre Singer, Professor ,MD 972-39376521 firstname.lastname@example.org|
|Contact: Milana Grinev, RN, Study Coordinator 972-39376521 email@example.com|
|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|