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

Primary Purpose

Post-Operative Pain

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Parecoxib Sodium
Sponsored by
Xianwei Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Operative Pain focused on measuring COX-2, PMNL, pain, macrophages, NSAIDs

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Normal Saline

Arm Description

Outcomes

Primary Outcome Measures

COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention
The individual differences in COX-2 expression
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

Secondary Outcome Measures

Inflammatory mediators detection: PEG2
The content of PEG2 in serum is detected by ELASA
Postoperative pain assessment
The visual analogue scale (VAS) at rest and patient controlled analgesia (PCA) sufentanyl consumption is assessed at all corresponding time points.

Full Information

First Posted
August 19, 2010
Last Updated
April 16, 2015
Sponsor
Xianwei Zhang
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01186159
Brief Title
The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain
Official Title
The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages and Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xianwei Zhang
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain
Keywords
COX-2, PMNL, pain, macrophages, NSAIDs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Parecoxib Sodium
Intervention Description
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.
Primary Outcome Measure Information:
Title
COX-2 mRNA and protein expression in PMNL and macrophages without drugs intervention
Description
The individual differences in COX-2 expression
Time Frame
6 month
Title
the expression of COX-2 in PMNL and macrophages after the COX-2 inhibitor was used
Description
The effects of COX-2 inhibitor on the expression of COX-2 in PMNL and macrophages
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Inflammatory mediators detection: PEG2
Description
The content of PEG2 in serum is detected by ELASA
Time Frame
4 month
Title
Postoperative pain assessment
Description
The visual analogue scale (VAS) at rest and patient controlled analgesia (PCA) sufentanyl consumption is assessed at all corresponding time points.
Time Frame
2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianwei Zhang, Doctor
Organizational Affiliation
Huazhong University of Science&Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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