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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Dietary supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA); Dietary supplement: Capsules (Placebo)

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Singer, Professor, MD; Phone Number: 972-3-9376521; Email: psinger@clalit.org.il
• Study Contact Backup: Name: Milana Grinev, RN, Study Coordinator; Phone Number: 972-3-9376521; Email: milang@clalit.org.il

Study Locations

• Israel
  • Petah Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center, Campus Beilinson
    • Contact: Pierre Singer, Professor,MD; Phone Number: 972-39376521; Email: psinger@clalit.org.il
    • Contact: Milana Grinev, RN, Study Coordinator; Phone Number: 972-39376521; Email: milang@clalit.org.il
    • Sub-Investigator: Sigal Frishman, RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Levels	Pain assessment of patients will be measured using visual analog scale (VAS) score.	10 weeks
Analgetics use	All analgetics drugs used by patient will be noted	10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (Estimate): January 12, 2011

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Knee; Fish Oil; Analgetics
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 5961