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Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial (EFOPaKR-01)

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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
Sponsor:
Information provided by (Responsible Party):
Pierre singer, Rabin Medical Center

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : January 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Fish oil

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fish oil group
Treatment 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
Placebo group
 Dietary Supplement: Capsules (Placebo)

Patient will receive capsules which not contain fish oil.

Treatment: 5 capsules per day


Outcome Measures
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Primary Outcome Measures :
  1. Pain Levels [ Time Frame: 10 weeks ]
    Pain assessment of patients will be measured using visual analog scale (VAS) score.

  2. Analgetics use [ Time Frame: 10 weeks ]
    All analgetics drugs used by patient will be noted


Secondary Outcome Measures :
  1. Inflammatory Markers [ Time Frame: Day 1 ]
    Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6).

  2. Fatty Acids Composition [ Time Frame: Day 1 ]
    ω3 incorporation into blood cell membranes(RBC)

  3. Cortisol [ Time Frame: Day 1 ]
    Cortisol levels in blood test.

  4. ACTH [ Time Frame: Day 1 ]
    ACTH levels in blood test.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274910


Contacts
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Contact: Pierre Singer, Professor, MD 972-3-9376521 psinger@clalit.org.il
Contact: Milana Grinev, RN, Study Coordinator 972-3-9376521 milang@clalit.org.il

Locations
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Israel
Rabin Medical Center, Campus Beilinson Recruiting
Petah Tikva, Israel, 49100
Contact: Pierre Singer, Professor,MD    972-39376521    psinger@clalit.org.il   
Contact: Milana Grinev, RN, Study Coordinator    972-39376521    milang@clalit.org.il   
Sub-Investigator: Sigal Frishman, RD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
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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
More Information
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Responsible Party: Pierre singer, Professor, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01274910    
Other Study ID Numbers: 5961
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: February 2013
Keywords provided by Pierre singer, Rabin Medical Center:
Fish Oil
Knee
Analgetics
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases