Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Perioperative Pain Control With Celecoxib (Celebrex) in Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00598234
First received: January 10, 2008
Last updated: June 20, 2010
Last verified: June 2010

January 10, 2008
June 20, 2010
September 2006
August 2009   (final data collection date for primary outcome measure)
VAS pain scores, range-of-motion, narcotics usage [ Time Frame: post-op 6hrs,12hrs,day1,day2,day3,day7 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00598234 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Perioperative Pain Control With Celecoxib (Celebrex) in Total Knee Arthroplasty
Perioperative Pain Control With Celecoxib (Celebrex) in Total Knee Arthroplasty

We propose that administration perioperative celecoxib is effective to control postoperative VAS pain scores, improve rehabilitation results, and decrease narcotics usage in total knee replacement patients.

Total knee replacement is an effective method to treat end-stage osteoarthritis. However, post-operative pain is still a bothering problem. Pre-emptive analgesia is defined as an antinociceptive treatment which prevents pain before its onset. Preoperative analgesia is thought more effective than an equal post-operative dose. Surgical trauma induces the synthesis of prostaglandins, which sensitize the peripheral nociceptors.Non-steroidal anti-inflammatory drugs (NSAIDs) inhibit prostaglandin synthesis both in the periphery and the spinal cord, therefore decreasing the post-operative hyperalgesic state.

Celebrex (Celecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat arthritis, pain, menstrual cramps, and colonic polyps. Prostaglandins are chemicals that are important contributors to the inflammation of arthritis that causes the pain, fever, swelling and tenderness. Celecoxib blocks the enzyme that makes prostaglandins (cyclooxygenase 2), resulting in lower concentrations of prostaglandins. As a consequence, inflammation and its accompanying pain, fever, swelling and tenderness are reduced. Celecoxib differs from other NSAIDs in that it causes less inflammation and ulceration of the stomach and intestine (at least with short-term treatment) and does not interfere with the clotting of blood.

The study group received 400mg oral celecoxib about 1 hr prior to total knee replacement surgery, and 200mg every 12 hrs, along with PCA morphine, over the first five post-operative days. The control group received placebo, along with PCA morphine over the same postoperative period. All patients had spinal anesthesia and hemovac drain tubes inserted for postoperative blood loss evaluation.

Specific aims and goals:

  1. to establish better rehabilitation results and lower VAS pain scores after administration perioperative celecoxib in total knee replacement patients.
  2. to establish morphine sparing effect after perioperative celecoxib administration.
  3. to evaluate the risks after prescribing perioperative celecoxib.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Osteoarthritis
Drug: Celecoxib (Celebrex)
The study group received 400mg oral celecoxib about 1 hr prior to surgery, and 200mg every 12 hrs, along with PCA morphine, over the first five post-operative days. The control group received placebo, along with PCA morphine over the same postoperative period. All patients received Acetaminophen 500mg qid for pain control.
  • Active Comparator: 1
    Celecoxib (Celebrex)
    Intervention: Drug: Celecoxib (Celebrex)
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Celecoxib (Celebrex)
Huang YM, Wang CM, Wang CT, Lin WP, Horng LC, Jiang CC. Perioperative celecoxib administration for pain management after total knee arthroplasty - a randomized, controlled study. BMC Musculoskelet Disord. 2008 Jun 3;9:77.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients receiving total knee replacement will be recruited in this study.

Exclusion Criteria:

  • subjects with end-stage renal disease, cerebral vascular accident, peptic ulcer, long-term usage of NSAIDs.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00598234
950704
No
Ching-Chuan Jiang, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Ching-Chuan Jiang, M.D.;Ph.D. National Taiwan University Hospital
National Taiwan University Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP