An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management in Total Knee Arthroplasty

Study Overview
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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

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

Official Title
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An Open Label,Multicentre, Randomized Trial to Determine the Efficacy of Periarticular Parecoxib Sodium In A Multimodal Cocktail vs Intravenous Parecoxib Sodium for Pain Management in Total Knee Arthroplasty

Conditions
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Unilateral Primary Osteoarthritis of Knee

Intervention / Treatment
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* Procedure: parecoxib sodium
* Procedure: parecoxib sodium


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: periarticular parecoxib sodium<br>patients will be given periarticular parecoxib sodium injection | Procedure: parecoxib sodium<br>* periarticular parecoxib sodium injection will be given during total knee arthroplasty<br>* Other names: dynastat;|
| Active Comparator: intravenous parecoxib sodium<br>intravenous parecoxib sodium will be given during total knee arthroplasty | Procedure: parecoxib sodium<br>* intravenous parecoxib sodium during total knee arthroplasty<br>* Other names: dynastat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain control | Post operative pain control( Visual Analogue Scale) with 0 corresponding to no pain and 10 to the worst imaginable pain. Pain will be measured 1st 6 hours, 12 hours, 24 hours and daily for 4 days. | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and duration of adverse events | Morphine consumption Metochlopromide usage during the 4 days Lactulose usage during the 4 days Range of motion measured by physiotherapist at 24 hours and daily for 4 days time to single leg raise time to ambulation | 4 days |