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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Post-Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Normal Saline

Group Type EXPERIMENTAL

Parecoxib Sodium

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No