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

OAIC1308/22

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.

2023-07-06

2024-04-01

2024-04-01

Recruiting

Early phase I

40

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-12-19