CompletedPhase 4

Parecoxib in Total Knee Arthroplasty

Chile40 participantsStarted 2023-07-06

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion Criteria: ASA I - III BMI 20 - 35 (kg/m2) Exclusion Criteria: * Adults who are not capable of giving their own consent * Pre-existing neuropathy (assessed in the history and physical examination) * Coagulation disturbance (assessed on history and physical examination, if clinically necessary, by blood test, i.e. platelets ≤ 100,000, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50) * Renal failure (assessed by history and physical examination, if considered clinically necessary, by blood test, i.e. creatinine ≥ 1.04 mg/dl) * Hepatic impairment (assessed by history and physical examination, if considered clinically necessary, by blood tests, i.e. transaminases (GGT ≥ 50 u/lt) * Allergy to local anesthetics, morphine, paracetamol, ketorolac or parecoxib * Pregnancy * Chronic pain syndromes that require the use of opioids at home * Known history of sulfa allergy * History of ischemic heart disease * History of chronic gastritis or peptic ulcer

What they're measuring

Morphine consumption

Timeframe: 24 hours

Trial details

NCT IDNCT05924412

SponsorUniversity of Chile

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01