CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Intravenous study drug +1 moredrug
Likely dose
Intravenous study drug 40mgfrom record
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Search/NCT05924412
NCT05924412Phase 4Completed

A Randomized Comparison Between Parecoxib and Placebo Added to a Standard Perioperative Analgesic Protocol for Total Knee Arthroplasty

University of Chile·interventional·Posted Jun 29, 2023·Updated May 15, 2025

In Brief

A Phase 4 clinical trial evaluating Intravenous study drug and Intravenous saline solution for Pain, Postoperative and 5 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedJun 29, 2023
Enrollment StartJul 6, 2023
Primary CompletionSep 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.0 years ago

Interventions

Intravenous study drugdrug

40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión

Intravenous saline solutionother

Saline solution (same volume as the study drug) will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incision