The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03095157

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief Summary

The aim of the study is to investigate whether pre-operative dysregulated systemic lipid mediator pathways are associated with increased risk for the development of persistent post surgical pain. In addition we will investigate whether treatment with an over the counter dietary supplement containing a fractionated marine lipid derivative from anchovy and sardine oil prevents the development of chronic pain after surgery.

Condition or Disease	Intervention/Treatment	Phase
Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled Persistent Post Surgical Pain	Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery

Anticipated Primary Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil Patients will be randomized to receive perioperative treatment versus placebo
Experimental: Treatment	Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil Patients will be randomized to receive perioperative treatment versus placebo

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil

Patients will be randomized to receive perioperative treatment versus placebo

Experimental: Treatment

Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil

Patients will be randomized to receive perioperative treatment versus placebo

Outcome Measures

Primary Outcome Measures

Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery [3 months]
Persistent pain after thoracic surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

scheduled to undergo esophagectomy at BWH
18-80 years old

Exclusion Criteria:

pre-existing chronic pain
current opioid use
current treatment with corticosteroids
evidence of active infection
chronic liver disease
end-stage renal disease (CKD-5)
chronic inflammatory disorders
recent major surgery or illness within 30 days
use of immunosuppressive medication
history of organ transplant
pregnancy or plans to become pregnant
lactating
allergies to fish or fish oil

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mieke A. Soens, MD Staff Anesthesiologist, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT03095157

Other Study ID Numbers:

2017P000346

First Posted:

Mar 29, 2017

Last Update Posted:

Mar 29, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Pain, Postoperative

Study Results

No Results Posted as of Mar 29, 2017