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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fractionated marine lipid concentrate derived from anchovy and sardine oil
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Treatment

    Arm Description

    Outcomes

    Primary Outcome Measures

    Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery
    Persistent pain after thoracic surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2017
    Last Updated
    March 23, 2017
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03095157
    Brief Title
    The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery
    Official Title
    The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    July 1, 2019 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled, Persistent Post Surgical Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Treatment
    Arm Type
    Experimental
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    fractionated marine lipid concentrate derived from anchovy and sardine oil
    Intervention Description
    Patients will be randomized to receive perioperative treatment versus placebo
    Primary Outcome Measure Information:
    Title
    Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery
    Description
    Persistent pain after thoracic surgery
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mieke Soens, MD
    Phone
    617-732-6798
    Email
    msoens@partners.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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