Post-Operative Pain
Conditions
Keywords
COX-2, PMNL, pain, macrophages, NSAIDs
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.
Interventions
DRUGParecoxib 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.
Sponsors
Pfizer
Xianwei Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention | 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 | 6 month | The effects of COX-2 inhibitor on the expression of COX-2 in PMNL and macrophages |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory mediators detection: PEG2 | 4 month | The content of PEG2 in serum is detected by ELASA |
| Postoperative pain assessment | 2 month | The visual analogue scale (VAS) at rest and patient controlled analgesia (PCA) sufentanyl consumption is assessed at all corresponding time points. |
Countries
China
Outcome results
None listed