Parecoxib in Total Knee Arthroplasty

University of Chile

Status and phase: Completed; Phase 4

Conditions: Analgesic Nephropathy; Pain, Acute; Pain, Postoperative; Analgesia; Knee Osteoarthritis; Analgesic Adverse Reaction

Treatments: Other: Intravenous saline solution; Drug: Intravenous study drug

Study type: Interventional

Funder types: Other

Identifiers

NCT05924412

OAIC1308/22

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Parecoxib

Experimental group

Description:

This arm will receive intravenous parecoxib in the intraoperative period.

Treatment:

Drug: Intravenous study drug

Placebo

Placebo Comparator group

Description:

This arm will receive a placebo intravenous injection containing saline solution in the same volume as the intervention group

Treatment:

Other: Intravenous saline solution