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

Mass General Brigham

Status: Unknown

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03095157

2017P000346

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

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

Treatment

Experimental group

Treatment:

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