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

August 19, 2010
June 27, 2011
November 2010
June 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01186159 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain
The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages 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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Inflammatory
  • Post-Operative Pain
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.
Experimental: Normal Saline
Intervention: Drug: Parecoxib Sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
90
September 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01186159
COX-2
Yes
Chen Anmin, Ethics Committee of Tongji Hospital Tongji Medical College Huazhong University of Science&Technology
Huazhong University of Science and Technology
Pfizer
Not Provided
Huazhong University of Science and Technology
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP