The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled to undergo esophagectomy at BWH
- •18-80 years old
排除标准
- •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
研究组 & 干预措施
Placebo
干预措施: fractionated marine lipid concentrate derived from anchovy and sardine oil (Dietary Supplement)
Treatment
干预措施: fractionated marine lipid concentrate derived from anchovy and sardine oil (Dietary Supplement)
结局指标
主要结局
Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery
时间窗: 3 months
Persistent pain after thoracic surgery
次要结局
未报告次要终点
研究者
Mieke A. Soens
MD Staff Anesthesiologist
Brigham and Women's Hospital