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

Post-Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186159
• Other study ID #: COX-2
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2010
• Last updated: April 16, 2015
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2015
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-Operative Pain

Intervention

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.

Locations

Country	Name	City	State
China	Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Xianwei Zhang	Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention	The individual differences in COX-2 expression	6 month	Yes
Primary	the expression of COX-2 in PMNL and macrophages after the COX-2 inhibitor was used	The effects of COX-2 inhibitor on the expression of COX-2 in PMNL and macrophages	6 month	Yes
Secondary	Inflammatory mediators detection: PEG2	The content of PEG2 in serum is detected by ELASA	4 month	Yes
Secondary	Postoperative pain assessment	The visual analogue scale (VAS) at rest and patient controlled analgesia (PCA) sufentanyl consumption is assessed at all corresponding time points.	2 month	Yes