Clinical trial NCT01311804: An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management in Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Unilateral Primary Osteoarthritis of Knee
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2011-03-10
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Post operative pain control
timeFrame: 4 days
Secondary outcomes:
measure: Number and duration of adverse events
timeFrame: 4 days
Other outcomes:
Locations:
city: Kangar
country: Malaysia
facility: Hospital Tuanku Fauziah
state: Perlis
Study officials:
affiliation: MOH Malaysia
name: Yeap Ewe Juan
role: PRINCIPAL_INVESTIGATOR
References: