MedDataX Logo

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

NCT ID: NCT01274910

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Fish Oil Knee Analgetics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fish oil group

Treatment Group.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

Patient will receive Fish Oil capsules (EPAX 6000 EE) .

Treatment: 5 capsules per day

Control group

Placebo group

Group Type PLACEBO_COMPARATOR

Capsules (Placebo)

Intervention Type DIETARY_SUPPLEMENT

Patient will receive capsules which not contain fish oil.

Treatment: 5 capsules per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Patient will receive Fish Oil capsules (EPAX 6000 EE) .

Treatment: 5 capsules per day

Intervention Type DIETARY_SUPPLEMENT

Capsules (Placebo)

Patient will receive capsules which not contain fish oil.

Treatment: 5 capsules per day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Caps.Omeguard Triomar 1000 mg SGC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pierre singer

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pierre Singer, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

ICU dep't, Rabin MC,Petah Tikva, Israel

Milana Grinev, RN, Study Coordinator

Role: STUDY_DIRECTOR

ICU dep't, Rabin MC, Petah Tikva, Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rabin Medical Center, Campus Beilinson

Petah Tikva, Petah Tikva, Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pierre Singer, Professor, MD

Role: CONTACT

Phone: 972-3-9376521

Email: [email protected]

Milana Grinev, RN, Study Coordinator

Role: CONTACT

Phone: 972-3-9376521

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pierre Singer, Professor,MD

Role: primary

Milana Grinev, RN, Study Coordinator

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5961

Identifier Type: -

Identifier Source: org_study_id