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

NCT01186159 | Completed Phase 4 DMC

• 1 other identifier: COX-2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Post-Operative Pain

Keywords

COX-2; PMNL; pain; macrophages; NSAIDs

Outcome Measures

Primary Outcomes (2)

• COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention

  The individual differences in COX-2 expression

  6 month

• 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

Secondary Outcomes (2)

• Inflammatory mediators detection: PEG2

  4 month

• Postoperative pain assessment

  2 month

Study Arms (1)

Normal Saline

EXPERIMENTAL

Drug: Parecoxib Sodium

Interventions

Parecoxib Sodium 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.

Normal Saline

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Xianwei Zhang: lead
• Pfizer: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

parecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Xianwei Zhang, Doctor

  Huazhong University of Science&Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

CN (1)