Correlation of Eicosanoid and Proresolving Lipid Mediator Temporal Profiles and Resolution of Pain After Thoracic Surgery
NCT ID: NCT03360175
Last Updated: 2017-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2017-12-11
2019-12-01
Brief Summary
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Detailed Description
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The study will address the following Specific Aims:
Specific Aim 1: To determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and day-to-day resolution of pain after thoracic surgery.
We hypothesize that patients who have slower resolution of pain after thoracic surgery have dysregulated systemic lipid mediator pathways when compared to those patients who have faster resolution of pain.
Specific Aim 2: To determine the effectiveness of perioperative SPM signature as a novel predictive marker for the development of persistent pain after surgery (PPSP).
We hypothesize that patients with dysregulated systemic lipid mediator pathways, more specifically up-regulated pro-inflammatory lipid mediator pathways and down-regulated pro-resolving lipid mediator pathways, are more likely to develop PPSP.
Specific Aim 3: To determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and quality of recovery after surgery, duration of hospital stay and complications.
We hypothesize that dysregulated lipid mediator profiles are associated with a decreased Quality of Recovery Score (QoR-15), prolonged hospital stay and increased rates of complications, such as problems with wound healing and infection.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Thoracic Surgery Patients
Inclusion criteria include: Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital, between the ages 18-85 years old. Exclusion criteria are: pre-existing chronic pain or 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 transplantation.
Pro-inflammatory eicosanoid and pro resolving lipid mediator temporal profiles will be determined pre-operatively, on post-operative day 1 and on post-operative day 14. In addition, daily pain scores will be recorded for 60 days after surgery and at 3, 6 and 12 months.
No intervention - observational study
No intervention - observational study
Interventions
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No intervention - observational study
No intervention - observational study
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital
Exclusion Criteria
* Current treatment with corticosteroids
* Evidence of active infection
* Chronic liver disease, end-stage renal disease (CKD-5), or chronic inflammatory disorders
* Recent major surgery or illness within 30 days
* Use of immunosuppressive medication
* History of organ transplantation.
18 Years
85 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Mieke A. Soens
MD Staff Anesthesiologist
Central Contacts
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Other Identifiers
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2017P002402
Identifier Type: -
Identifier Source: org_study_id