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

Clalit Health Services

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA); Dietary Supplement: Capsules (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT01274910

5961

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Fish oil group

Active Comparator group

Description:

Treatment Group.

Treatment:

Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)

Control group

Placebo Comparator group

Description:

Placebo group

Treatment:

Dietary Supplement: Capsules (Placebo)