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

NCT ID: NCT03095157

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

fractionated marine lipid concentrate derived from anchovy and sardine oil

Intervention Type: DIETARY_SUPPLEMENT

Patients will be randomized to receive perioperative treatment versus placebo

Treatment

Group Type: EXPERIMENTAL

fractionated marine lipid concentrate derived from anchovy and sardine oil

Intervention Type: DIETARY_SUPPLEMENT

Patients will be randomized to receive perioperative treatment versus placebo

Interventions

fractionated marine lipid concentrate derived from anchovy and sardine oil

Patients will be randomized to receive perioperative treatment versus placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mieke A. Soens

MD Staff Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mieke Soens, MD

Role: CONTACT

msoens@partners.org

617-732-6798

Other Identifiers

2017P000346

Identifier Type: -

Identifier Source: org_study_id