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

Phase 4
Completed
Conditions
Post-Operative Pain
Interventions
Registration Number
NCT01186159
Lead Sponsor
Xianwei Zhang
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Normal SalineParecoxib Sodium-
Primary Outcome Measures
NameTimeMethod
COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention6 month

The individual differences in COX-2 expression

the expression of COX-2 in PMNL and macrophages after the COX-2 inhibitor was used6 month

The effects of COX-2 inhibitor on the expression of COX-2 in PMNL and macrophages

Secondary Outcome Measures
NameTimeMethod
Inflammatory mediators detection: PEG24 month

The content of PEG2 in serum is detected by ELASA

Postoperative pain assessment2 month

The visual analogue scale (VAS) at rest and patient controlled analgesia (PCA) sufentanyl consumption is assessed at all corresponding time points.

Trial Locations

Locations (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

🇨🇳

Wuhan, Hubei, China

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