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

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.

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Celecoxib (Celebrex)
• Placebo Comparator: 2
  • Placebo

Primary Measures

• VAS pain scores, range-of-motion, narcotics usage
  • Time Frame: post-op 6hrs,12hrs,day1,day2,day3,day7
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Taiwan University Hospital Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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