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| ID | Type | Description | Link |
|---|---|---|---|
| Ministry of Health | Other Grant/Funding Number | MOH |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| periarticular parecoxib sodium | Experimental | patients will be given periarticular parecoxib sodium injection |
|
| intravenous parecoxib sodium | Active Comparator | intravenous parecoxib sodium will be given during total knee arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| parecoxib sodium | Procedure | periarticular parecoxib sodium injection will be given during total knee arthroplasty |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and duration of adverse events |
| 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanthini Govindasamy | Contact | +603-26924249 | shanthini@crc.gov.my |
| Name | Affiliation | Role |
|---|---|---|
| Yeap Ewe Juan | MOH Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Tuanku Fauziah | Kangar | Perlis | 01000 | Malaysia |
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| ID | Term |
|---|---|
| C409945 | parecoxib |
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| parecoxib sodium | Procedure | intravenous parecoxib sodium during total knee arthroplasty |
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