Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Reduction of chronic post-surgical pain
研究概览
简要总结
Postsurgical pain becomes chronic when it lasts more then two months after surgery. A neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates after urologic and gynecologic surgeries.
Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors release, without adverse events.
The investigators assume that perioperative administration of PEA can reduce chronic postsurgical pain incidence of patients undergoing to urologic and gynecologic elective 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective gynecological or urological surgical procedures
排除标准
- •age < 18
- •pregnancy or nursing
- •pre-existing chronic pain
- •severe hepatic or renal failure
- •post-operative progression of local cancer disease
- •post-operative infection or inflammation of surgical wound
结局指标
主要结局
Reduction of chronic post-surgical pain
时间窗: 2 months after surgery
Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound.
次要结局
未报告次要终点
研究者
Laura Rinaldi
Medical Doctor
University of Modena and Reggio Emilia