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

Status: Completed
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• ASA I - III BMI 20 - 35 (kg/m2)

Locations
Other Locations
Chile
Hospital Clinico Universidad de Chile
Santiago
Time Frame
Start Date: 2023-07-06
Completion Date: 2024-09-01
Participants
Target number of participants: 40
Treatments
Experimental: Parecoxib
This arm will receive intravenous parecoxib in the intraoperative period.
Placebo_comparator: Placebo
This arm will receive a placebo intravenous injection containing saline solution in the same volume as the intervention group
Sponsors
Leads: University of Chile

This content was sourced from clinicaltrials.gov