Perioperative Pain Control With Celecoxib (Celebrex) in Total Knee Arthroplasty
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Perioperative Pain Control With Celecoxib (Celebrex) in Total Knee Arthroplasty |
- VAS pain scores, range-of-motion, narcotics usage [ Time Frame: post-op 6hrs,12hrs,day1,day2,day3,day7 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2006 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Celecoxib (Celebrex)
|
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.
|
|
Placebo Comparator: 2
Placebo
|
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.
|
Detailed Description:
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:
- to establish better rehabilitation results and lower VAS pain scores after administration perioperative celecoxib in total knee replacement patients.
- to establish morphine sparing effect after perioperative celecoxib administration.
- to evaluate the risks after prescribing perioperative celecoxib.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | 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.
Contacts and Locations More Information
No publications provided by National Taiwan University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ching-Chuan Jiang, National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00598234 History of Changes |
| Other Study ID Numbers: | 950704 |
| Study First Received: | January 10, 2008 |
| Last Updated: | June 20, 2010 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013