The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain
NCT01186159
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- 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)
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain | |||
| Official Title ICMJE | The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages and Postoperative Pain | |||
| 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Post-Operative Pain | |||
| Intervention ICMJE | 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. | |||
| Study Arms ICMJE | Experimental: Normal Saline
Intervention: Drug: Parecoxib Sodium | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 90 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | September 2011 | |||
| Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 20 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | China | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01186159 | |||
| Other Study ID Numbers ICMJE | COX-2 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Xianwei Zhang, Huazhong University of Science and Technology | |||
| Study Sponsor ICMJE | Xianwei Zhang | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Huazhong University of Science and Technology | |||
| Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||