The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages and Postoperative Pain|
- COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]The individual differences in COX-2 expression
- the expression of COX-2 in PMNL and macrophages after the COX-2 inhibitor was used [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]The effects of COX-2 inhibitor on the expression of COX-2 in PMNL and macrophages
- Inflammatory mediators detection: PEG2 [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]The content of PEG2 in serum is detected by ELASA
- Postoperative pain assessment [ Time Frame: 2 month ] [ Designated as safety issue: Yes ]The visual analogue scale (VAS) at rest and patient controlled analgesia (PCA) sufentanyl consumption is assessed at all corresponding time points.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
|Experimental: Normal Saline||
Drug: Parecoxib Sodium
40 mg Parecoxib Sodium is give to the patients intravenously (diluted with 5 ml normal saline) at 30 minutes before surgery, 20 mg Parecoxib Sodium (diluted with 5 ml normal saline) at 8 hours,20 hours,32 hours,44 hours,56 hours after surgery respectively.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186159
|Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology|
|Wuhan, Hubei, China, 430030|