Status:
COMPLETED
The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain
Lead Sponsor:
Xianwei Zhang
Collaborating Sponsors:
Pfizer
Conditions:
Post-Operative Pain
Eligibility:
All Genders
20-55 years
Phase:
PHASE4
Brief Summary
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
Detailed Description
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 peripher...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01186159
Start Date
November 1 2010
End Date
September 1 2011
Last Update
April 17 2015
Active Locations (1)
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1
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030