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

Rheumatoid Arthritis Clinical Trial

— EFOPaKR-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01274910
• Other study ID #: 5961
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2011
• Last updated: November 21, 2013
• Start date: January 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2013
• Source: Rabin Medical Center
• Contact: Pierre Singer, Professor, MD
• Phone: 972-3-9376521
• Email: psinger[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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
• Capsules (Placebo)
Patient will receive capsules which not contain fish oil. Treatment: 5 capsules per day

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Campus Beilinson	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Levels	Pain assessment of patients will be measured using visual analog scale (VAS) score.	10 weeks	No
Primary	Analgetics use	All analgetics drugs used by patient will be noted	10 weeks	No
Secondary	Inflammatory Markers	Blood test. Concentration of circulated inflammatory markers (TNF-a,IL-1,IL-6).	Day 1	No
Secondary	Fatty Acids Composition	?3 incorporation into blood cell membranes(RBC)	Day 1	No
Secondary	Cortisol	Cortisol levels in blood test.	Day 1	No
Secondary	ACTH	ACTH levels in blood test.	Day 1	No