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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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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 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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Celecoxib (Celebrex)

Group Type ACTIVE_COMPARATOR

Celecoxib (Celebrex)

Intervention Type DRUG

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.

2

Placebo

Group Type PLACEBO_COMPARATOR

Celecoxib (Celebrex)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG