NCT01311804

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Ministry of Health, Malaysia · Other Government
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Unilateral Primary Osteoarthritis of Knee

Interventions

Type	Name	Description
PROCEDURE	parecoxib sodium	periarticular parecoxib sodium injection will be given during total knee arthroplasty
PROCEDURE	parecoxib sodium	intravenous parecoxib sodium during total knee arthroplasty

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-04-01
• Completion: 2011-10-01
• First posted: 2011-03-10
• Last updated: 2011-03-10

Locations

1 site across 1 country: Malaysia