Clinical trial NCT01186159: The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain
Official title: The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages and Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Operative Pain
Keywords: COX-2
PMNL
pain
macrophages
NSAIDs
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-08-23
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention
timeFrame: 6 month
measure: the expression of COX-2 in PMNL and macrophages after the COX-2 inhibitor was used
timeFrame: 6 month
Secondary outcomes:
measure: Inflammatory mediators detection: PEG2
timeFrame: 4 month
measure: Postoperative pain assessment
timeFrame: 2 month
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science&Technology
name: Xianwei Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: