Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled, Persistent Post Surgical Pain
Conditions
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.
Interventions
DIETARY_SUPPLEMENTfractionated marine lipid concentrate derived from anchovy and sardine oil
Patients will be randomized to receive perioperative treatment versus placebo
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery | 3 months | Persistent pain after thoracic surgery |
Contacts
Primary ContactMieke Soens, MD
Outcome results
None listed