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

Brigham and Women's Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled Persistent Post Surgical Pain

Interventions

fractionated marine lipid concentrate derived from anchovy and sardine oilDIETARY_SUPPLEMENT

Patients will be randomized to receive perioperative treatment versus placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Persistent pain after thoracic surgery

Time frame: 3 months

Central Contacts

Mieke Soens, MD

CONTACT

617-732-6798 msoens@partners.org

Data from ClinicalTrials.gov

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