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

Unilateral Primary Osteoarthritis of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01311804
• Other study ID #: 02-2010
• Secondary ID: Ministry of Heal
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 3, 2011
• Last updated: March 8, 2011
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2011
• Source: Ministry of Health, Malaysia
• Contact: Shanthini Govindasamy
• Phone: +603-26924249
• Email: shanthini[@]crc.gov.my
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: October 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Unilateral Primary Osteoarthritis of Knee

Intervention

Procedure:
• parecoxib sodium
periarticular parecoxib sodium injection will be given during total knee arthroplasty
• parecoxib sodium
intravenous parecoxib sodium during total knee arthroplasty

Locations

Country	Name	City	State
Malaysia	Hospital Tuanku Fauziah	Kangar	Perlis

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No