Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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 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.

Primary:

• VAS pain scores, range-of-motion, narcotics usage post-op 6hrs,12hrs,day1,day2,day3,day7 No

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.

Lead Sponsor: National Taiwan University Hospital

Ching-Chuan Jiang

Taipei city   Taiwan

Overall Clinical Trial Officials and Contacts

Ching-Chuan Jiang, M.D.;Ph.D. Principal Investigator National Taiwan University Hospital  

Overall Contact: Ching-Chung Jiang, M.D.;Ph.D. 886-2-23123456 ccj@ntu.edu.tw

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00598234

Study ID Number: 950704

ClinicalTrials.gov Identifier: NCT00598234

Health Authority: Taiwan: Department of Health