An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management 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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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Primary Research Objective:

The primary objective of this study is to determine efficacy of periarticular parecoxib sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management in total knee arthroplasty

Secondary Research Objective:

* To determine if perioperative use of parecoxib sodium was associated with improved clinical outcomes
* To evaluate the safety, in terms of adverse events; serious adverse events and tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail

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Detailed Description

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This is a multi-center, open label, parallel randomized trial designed to evaluate the efficacy and safety of periarticular parecoxib sodium compared to intravenous parecoxib sodium.

125 patients with primary knee osteoarthritis from 4 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then randomly allocated to periarticular parecoxib sodium or intravenous sodium in ratio of 1:1. patients are observed at post-operative 6, 12, 24 hours, subsequently daily for 4 days and finally at 2 week follow-up

Conditions

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Unilateral Primary Osteoarthritis of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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periarticular parecoxib sodium

patients will be given periarticular parecoxib sodium injection

Group Type EXPERIMENTAL

parecoxib sodium

Intervention Type PROCEDURE

periarticular parecoxib sodium injection will be given during total knee arthroplasty

intravenous parecoxib sodium

intravenous parecoxib sodium will be given during total knee arthroplasty

Group Type ACTIVE_COMPARATOR

parecoxib sodium

Intervention Type PROCEDURE

intravenous parecoxib sodium during total knee arthroplasty

Interventions

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parecoxib sodium

periarticular parecoxib sodium injection will be given during total knee arthroplasty

Intervention Type PROCEDURE

parecoxib sodium

intravenous parecoxib sodium during total knee arthroplasty

Intervention Type PROCEDURE

Other Intervention Names

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dynastat dynastat

Eligibility Criteria

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Inclusion Criteria

* Patients with primary knee osteoarthritis on treatment and planned for unilateral total knee arthroplasty and on spinal/general anesthesia
* Subjects age more than 50 and less than 85 years
* Patients with body weight at least 50 kg and not more than 50%above ideal body weight
* Written informed consent obtained from patient or guardian

Exclusion Criteria

* Female patients who are attempting to conceive/pregnant
* Known allergy or hypersensitivity to cocktail regime or to COX-2 inhibitors
* History of bleeding disorders or coagulation defect
* Patients with abnormal liver profile
* Patients with history of stroke or major neurological defect
* Patients with neuropathic pain/sensory disorder
* Patients with peptic ulceration or anticoagulant use within 1 month
* History of previous major knee surgery/trauma
* Patients with renal insufficiency
* History of revision total knee arthroplasty
* Patients with knee deformity \> 20 degrees
* Patients planned for bilateral knee arthroplasty during the same setting
* Patients with significant bone loss requiring augmentation
* Patients with history of using NSAIDs 24 hours before the surgery

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No