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临床试验/NCT03360175
NCT03360175Unknown不适用

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

Brigham and Women's Hospital0 个研究点目标入组 40 人开始时间: 2017年12月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
time course of pain resolution after thoracic surgery

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

time course of pain resolution after thoracic surgery

时间窗: 12 months

次要结局

  • incidence of persistent pain after thoracic surgery(18 months)
  • Quality of Recovery after thoracic surgery(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mieke A. Soens

MD Staff Anesthesiologist

Brigham and Women's Hospital

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