The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages and Postoperative Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention
研究概览
简要总结
To investigate the dose-effect relations among the expression of COX-2 in polymorphonuclear leukocytes (PMNL) and macrophages, systemic and local inflammatory response and postoperative pain
详细描述
we detect COX-2mRNA, COX-2 protein expression in inflammatory cells and PGE2 concentration in patients with abdominal surgery. The differences of COX-2 expression in PMNL are compared between peripheral blood and partial incision transudate to the same individual, and at the same time, the COX-2 expression differences in PMNL and macrophages, and PGE2 concentration in partial incision transudate also compared interindividually, to show the relevance between the difference and postoperative pain. In addition, the effects of Parecoxib Sodium on COX-2 expression of the amount in PMNL and macrophages are investigated during the development of postoperative inflammatory pain. Finally, we will clear the dose-effect relations among the expression of COX-2 in inflammatory cell, systemic and local inflammatory response and postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The trial is approved by Tongji hospital's Ethics Committee, Tongji Medical College of Huazhong University of Science and Technology, and is registered through Clinical Trail. All patients give written informed consent
- •American Society of Anesthesiologists (ASA) physical status of I or II
- •20 years to 55 years
- •Weight 50 ~ 70 kg, BMI 19 ~ 24
- •Duration of operation time in the range of 2-4 hours
- •A normal leukocytes level before the operation
- •No alcohol or smoking abuse
- •Without major trauma, history of psychiatric disease and history of chronic pain
- •Patients agreement with the trial and having ability to complete the requirements of this study
- •Patients receiving intravenous patient controlled analgesia (PCA)
排除标准
- •Allergy or contraindication to selective COX-2 inhibitors
- •Received NSAIDs treatments before the operation
- •Used enzyme inhibitor (such as Ketoconazole, Fluconazole, Itraconazole), enzyme inducer (such as Rifampicin, Phenytoin sodium, Carbamazepine, Dexamethasone), anticoagulant (such as Warfarin, Aspirin) and other drugs which increase the drug toxicity (such as Erythromycin, Clarithromycin, Cyclosporin Ciclosporin, ACE inhibitor or Diuretics, Lithium) from the first 3 days before the operation to postoperative observation period
- •Blood transfusion, hemodilution measures in the operation
- •Infection of the incision
研究组 & 干预措施
Normal Saline
干预措施: Parecoxib Sodium (Drug)
结局指标
主要结局
COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention
时间窗: 6 month
The individual differences in COX-2 expression
the expression of COX-2 in PMNL and macrophages after the COX-2 inhibitor was used
时间窗: 6 month
The effects of COX-2 inhibitor on the expression of COX-2 in PMNL and macrophages
次要结局
- Inflammatory mediators detection: PEG2(4 month)
- Postoperative pain assessment(2 month)
研究者
Xianwei Zhang
Clinical Professor
Huazhong University of Science and Technology