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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03095157
Other study ID # 2017P000346
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 16, 2017
Last updated March 23, 2017

Study information

Verified date March 2017
Source Brigham and Women's Hospital
Contact Mieke Soens, MD
Phone 617-732-6798
Email msoens@partners.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
fractionated marine lipid concentrate derived from anchovy and sardine oil
Patients will be randomized to receive perioperative treatment versus placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery Persistent pain after thoracic surgery 3 months