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| Sponsor: | National Taiwan University Hospital |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00598234 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: Celecoxib (Celebrex) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Perioperative Pain Control With Celecoxib (Celebrex) in Total Knee Arthroplasty |
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 2: Active Comparator |
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 PCA morphine over the same postoperative period. All patients received Acetaminophen 500mg qid for pain control.
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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:
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ching-Chung Jiang, M.D.;Ph.D. | 886-2-23123456 ext 5273 | ccj@ntu.edu.tw |
| Taiwan | |
| Ching-Chuan Jiang | Recruiting |
| Taipei city, Taiwan | |
| Contact: Ching-Chuan Jiang, M.D.;Ph.D. 886-2-23123456 ext 5273 ccj@ntu.edu.tw | |
| Principal Investigator: Ching-Chuan Jiang, M.D.;Ph.D. | |
| Principal Investigator: | Ching-Chuan Jiang, M.D.;Ph.D. | National Taiwan University Hospital |
More Information
| Responsible Party: | National Taiwan University Hospital ( Ching-Chuan Jiang ) |
| Study ID Numbers: | 950704 |
| Study First Received: | January 10, 2008 |
| Last Updated: | January 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00598234 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Osteoarthritis Joint Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Rheumatic Diseases Pharmacologic Actions |
Musculoskeletal Diseases Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Arthritis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |