The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Pfizer

Information provided by:

Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01186159

First received: August 19, 2010

Last updated: June 27, 2011

Last verified: August 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	August 19, 2010
Last Updated Date	June 27, 2011
Start Date ^ICMJE	November 2010
Estimated Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 20, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01186159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 20, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Inflammatory 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 Arm (s)	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	Enrolling by invitation
Estimated Enrollment ^ICMJE	90
Estimated Completion Date	September 2011
Estimated Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01186159
Other Study ID Numbers ^ICMJE	COX-2
Has Data Monitoring Committee	Yes
Responsible Party	Chen Anmin, Ethics Committee of Tongji Hospital Tongji Medical College Huazhong University of Science&Technology
Study Sponsor ^ICMJE	Huazhong University of Science and Technology
Collaborators ^ICMJE	Pfizer
Investigators ^ICMJE	Not Provided
Information Provided By	Huazhong University of Science and Technology
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top