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
  Purpose

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


Condition Intervention Phase
Inflammatory
Post-Operative Pain
Drug: Parecoxib Sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages and Postoperative Pain

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: November 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal Saline 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186159

Locations
China, Hubei
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Pfizer
  More Information

No publications provided

Responsible Party: Chen Anmin, Ethics Committee of Tongji Hospital Tongji Medical College Huazhong University of Science&Technology
ClinicalTrials.gov Identifier: NCT01186159     History of Changes
Other Study ID Numbers: COX-2
Study First Received: August 19, 2010
Last Updated: June 27, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Huazhong University of Science and Technology:
COX-2
PMNL
pain
macrophages
NSAIDs

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Parecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 22, 2014