Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled Clinical Trial
Official title:
The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery
| 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 |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Brigham and Women's Hospital |
| 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 |