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

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

Study Overview

• Status: Unknown
• Conditions: Unilateral Primary Osteoarthritis of Knee
• Intervention / Treatment: Procedure: parecoxib sodium; Procedure: parecoxib sodium

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

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shanthini Govindasamy; Phone Number: +603-26924249; Email: shanthini@crc.gov.my

Study Locations

• Malaysia
  • Perlis
    • Kangar, Perlis, Malaysia, 01000
      • Hospital Tuanku Fauziah
      • Contact: Yeap Ewe Juan; Phone Number: +604-976 3333
      • Principal Investigator: Yeap Ewe Juan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: periarticular parecoxib sodium; patients will be given periarticular parecoxib sodium injection	Procedure: parecoxib sodium; periarticular parecoxib sodium injection will be given during total knee arthroplasty; Other Names: dynastat; Procedure: parecoxib sodium; intravenous parecoxib sodium during total knee arthroplasty; Other Names: dynastat
Active Comparator: intravenous parecoxib sodium; intravenous parecoxib sodium will be given during total knee arthroplasty	Procedure: parecoxib sodium; periarticular parecoxib sodium injection will be given during total knee arthroplasty; Other Names: dynastat; Procedure: parecoxib sodium; intravenous parecoxib sodium during total knee arthroplasty; Other Names: dynastat

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ministry of Health, Malaysia
• Investigators: Principal Investigator: Yeap Ewe Juan, MOH Malaysia

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): April 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: March 3, 2011
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Estimate): March 10, 2011
• Last Update Submitted That Met QC Criteria: March 8, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Parecoxib
• Other Study ID Numbers: 02-2010; Ministry of health (Sevcan Arzu ARINKAN-2020-05-03T22_54_16)