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

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA); Dietary Supplement: Capsules (Placebo)

• Registration Number: NCT01274910
• Lead Sponsor: Rabin Medical Center

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:

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil group	EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)	Treatment Group.
Control group	Capsules (Placebo)	Placebo group

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rabin Medical Center, Campus Beilinson; 🇮🇱 Petah Tikva, Israel