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

NCT01186159

Last updated date
Study Location
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Post-Operative Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
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
 (submitted: August 20, 2010)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Xianwei Zhang, DoctorHuazhong University of Science&Technology
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