Correlation of Eicosanoid and Proresolving Lipid Mediator Temporal Profiles and Resolution of Pain After Thoracic Surgery

• Conditions: Pain, Postoperative
• Interventions: Other: No intervention - observational study

• Registration Number: NCT03360175
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-11-28
• Last Update Submitted: 2017-11-28
• Study First Posted: 2017-12-04
• Last Update Posted: 2017-12-04
• Study Start: 2017-12-11
• Primary Completion: 2019-07-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thoracic Surgery Patients	No intervention - observational study	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.

Primary Outcome Measures

Name	Time	Method
time course of pain resolution after thoracic surgery	12 months

Secondary Outcome Measures

Name	Time	Method
incidence of persistent pain after thoracic surgery	18 months
Quality of Recovery after thoracic surgery	12 months