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

This study is not yet open for participant recruitment.
Verified December 2010 by Rabin Medical Center
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01274910
First received: January 4, 2011
Last updated: January 11, 2011
Last verified: December 2010
History of Changes
  Purpose

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 Intervention
Rheumatoid Arthritis
 Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)
Dietary Supplement: Capsules (Placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Pain Levels [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Pain assessment of patients will be measured using visual analog scale (VAS) score.

  • Analgetics use [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    All analgetics drugs used by patient will be noted


Secondary Outcome Measures:
  • Inflammatory Markers [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6).

  • Fatty Acids Composition [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    ω3 incorporation into blood cell membranes(RBC)

  • Cortisol [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Cortisol levels in blood test.

  • ACTH [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    ACTH levels in blood test.


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274910

Contacts
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
Israel
Rabin Medical Center, Campus Beilinson Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Pierre Singer, Professor ,MD     972-39376521     psinger@clalit.org.il    
Contact: Milana Grinev, RN, Study Coordinator         milang@clalit.org.il    
Sub-Investigator: Sigal Frishman, RD            
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
  More Information

No publications provided

Responsible Party: Prof. P.Singer,MD, Rabin Medical Center/Clalit
ClinicalTrials.gov Identifier: NCT01274910     History of Changes
Other Study ID Numbers: 5961
Study First Received: January 4, 2011
Last Updated: January 11, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Fish Oil
Knee
Analgetics

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 18, 2012