Trials / Completed
CompletedNCT05924412
Parecoxib in Total Knee Arthroplasty
A Randomized Comparison Between Parecoxib and Placebo Added to a Standard Perioperative Analgesic Protocol for Total Knee Arthroplasty
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- University of Chile · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Early mobilization and rehabilitation can be difficult after total knee arthroplasty (TKA) due to a high incidence of moderate to severe postoperative pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are important to multimodal analgesic protocols. Parecoxib is an NSAID that selectively inhibits the enzyme cyclooxygenase-2 (COX-2). Clinical trials have shown that it does not alter platelet function or gastric mucosa. A recent study, after comparing ketorolac and parecoxib used at the same time in infiltration and systemically, found no differences in perioperative analgesia with a tendency to less bleeding in the parecoxib group. This randomized study will compare the effectiveness of adding a COX-2 inhibitor in the pain management of patients undergoing TKA as part of a multimodal analgesia regimen. The morphine consumption was selected as the primary outcome. The study hypothesis is that patients receiving parecoxib would have a lower opioid consumption.
Conditions
- Pain, Postoperative
- Pain, Acute
- Analgesia
- Analgesic Nephropathy
- Analgesic Adverse Reaction
- Knee Osteoarthritis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intravenous study drug | 40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión |
| OTHER | Intravenous saline solution | Saline solution (same volume as the study drug) will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incision |
Timeline
- Start date
- 2023-07-06
- Primary completion
- 2024-09-01
- Completion
- 2024-09-01
- First posted
- 2023-06-29
- Last updated
- 2025-05-15
Locations
1 site across 1 country: Chile
Source: ClinicalTrials.gov record NCT05924412. Inclusion in this directory is not an endorsement.