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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)
Capsules (Placebo)
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Fish Oil, Knee, Analgetics

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rabin Medical Center, Campus BeilinsonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fish oil group

Control group

Arm Description

Treatment Group.

Placebo group

Outcomes

Primary Outcome Measures

Pain Levels
Pain assessment of patients will be measured using visual analog scale (VAS) score.
Analgetics use
All analgetics drugs used by patient will be noted

Secondary Outcome Measures

Inflammatory Markers
Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6).
Fatty Acids Composition
ω3 incorporation into blood cell membranes(RBC)
Cortisol
Cortisol levels in blood test.
ACTH
ACTH levels in blood test.

Full Information

First Posted
January 4, 2011
Last Updated
November 21, 2013
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01274910
Brief Title
Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial
Acronym
EFOPaKR-01
Official Title
Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
Primary outcome: Post surgical pain level and analgesics use Secondary outcomes: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Fish Oil, Knee, Analgetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fish oil group
Arm Type
Active Comparator
Arm Description
Treatment Group.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Dietary Supplement
Intervention Name(s)
EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)
Other Intervention Name(s)
Caps.Omeguard Triomar 1000 mg SGC
Intervention Description
Patient will receive Fish Oil capsules (EPAX 6000 EE) . Treatment: 5 capsules per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Capsules (Placebo)
Intervention Description
Patient will receive capsules which not contain fish oil. Treatment: 5 capsules per day
Primary Outcome Measure Information:
Title
Pain Levels
Description
Pain assessment of patients will be measured using visual analog scale (VAS) score.
Time Frame
10 weeks
Title
Analgetics use
Description
All analgetics drugs used by patient will be noted
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Inflammatory Markers
Description
Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6).
Time Frame
Day 1
Title
Fatty Acids Composition
Description
ω3 incorporation into blood cell membranes(RBC)
Time Frame
Day 1
Title
Cortisol
Description
Cortisol levels in blood test.
Time Frame
Day 1
Title
ACTH
Description
ACTH levels in blood test.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Singer, Professor, MD
Phone
972-3-9376521
Email
psinger@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Milana Grinev, RN, Study Coordinator
Phone
972-3-9376521
Email
milang@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Singer, Professor, MD
Organizational Affiliation
ICU dep't, Rabin MC,Petah Tikva, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Milana Grinev, RN, Study Coordinator
Organizational Affiliation
ICU dep't, Rabin MC, Petah Tikva, Israel
Official's Role
Study Director
Facility Information:
Facility Name
Rabin Medical Center, Campus Beilinson
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Singer, Professor,MD
Phone
972-39376521
Email
psinger@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Milana Grinev, RN, Study Coordinator
Phone
972-39376521
Email
milang@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Sigal Frishman, RD

12. IPD Sharing Statement

Learn more about this trial

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

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