Clinical trial NCT03360175: Correlation of Eicosanoid and Proresolving Lipid Mediator Temporal Profiles and Resolution of Pain After Thoracic Surgery
Official title: Correlation of Eicosanoid and Proresolving Lipid Mediator Temporal Profiles and Resolution of Pain After Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital

Brief summary: The aim of the current pilot study is to investigate whether perioperative dysregulated systemic lipid mediator pathways (more specifically increased pro-inflammatory and decreased anti-inflammatory pathways) are associated with slower resolution of pain after surgery and increased risk for development of persistent postsurgical pain (PPSP). In addition, we will look for correlations between the pro-resolving lipid mediator profile and Quality of Recovery (QoR-15), duration of hospital stay, and frequency of complications, e.g. wound infections.

Detailed description: This is a prospective, observational pilot study that will assess whether 1) a peri-operative dysregulated metabolo-lipidomics or SPM profile is associated with slower resolution of pain after surgery and an increased risk for development of persistent postsurgical pain (PPSP), and 2) whether a peri-operative dysregulated metabolo-lipidomics profile correlates with low Quality of Recovery (QoR-15) scores, duration of hospital stay and frequency of complications, e.g. wound infection.

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.

Eligibility criteria: Inclusion Criteria:

* Age 18-85
* Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital

Exclusion Criteria:

* Pre-existing chronic pain or opioid use
* 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.

Primary outcomes:
measure: time course of pain resolution after thoracic surgery
timeFrame: 12 months
Secondary outcomes:
measure: incidence of persistent pain after thoracic surgery
timeFrame: 18 months
measure: Quality of Recovery after thoracic surgery
timeFrame: 12 months
Other outcomes:
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