Unilateral Primary Osteoarthritis of Knee
Conditions
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
Interventions
PROCEDUREparecoxib sodium
periarticular parecoxib sodium injection will be given during total knee arthroplasty
Sponsors
Ministry of Health, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain control | 4 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and duration of adverse events | 4 days | * 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 |
Countries
Malaysia
Contacts
Primary ContactShanthini Govindasamy
Outcome results
None listed