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

Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01274910
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
36
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)
  • Dietary Supplement: Capsules (Placebo)
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
Jan 1, 2014

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. Pain Levels [10 weeks]

      Pain assessment of patients will be measured using visual analog scale (VAS) score.

    2. Analgetics use [10 weeks]

      All analgetics drugs used by patient will be noted

    Secondary Outcome Measures

    1. Inflammatory Markers [Day 1]

      Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6).

    2. Fatty Acids Composition [Day 1]

      ω3 incorporation into blood cell membranes(RBC)

    3. Cortisol [Day 1]

      Cortisol levels in blood test.

    4. ACTH [Day 1]

      ACTH levels in blood test.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Rabin Medical Center, Campus Beilinson Petah Tikva Israel 49100

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pierre singer, Professor, MD, Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT01274910
    Other Study ID Numbers:
    • 5961
    First Posted:
    Jan 12, 2011
    Last Update Posted:
    Nov 25, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Pierre singer, Professor, MD, Rabin Medical Center
    Fish Oil
    Knee
    Analgetics
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Nov 25, 2013