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Clinical Trials/NCT00598234
NCT00598234CompletedPhase 4

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

National Taiwan University Hospital1 site in 1 country120 target enrollmentStarted: September 2006Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
VAS pain scores, range-of-motion, narcotics usage

Study Overview

Brief Summary

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.

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:

  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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
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.

Arms & Interventions

1

Active Comparator

Celecoxib (Celebrex)

Intervention: Celecoxib (Celebrex) (Drug)

2

Placebo Comparator

Placebo

Intervention: Celecoxib (Celebrex) (Drug)

Outcomes

Primary Outcomes

VAS pain scores, range-of-motion, narcotics usage

Time Frame: post-op 6hrs,12hrs,day1,day2,day3,day7

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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