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Completed

NCT Number: NCT05924412

Parecoxib in Total Knee Arthroplasty

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.

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Key information

Conditions

Pain, Postoperative Acute Pain Agnosia Analgesia Analgesic Adverse Reaction Analgesic Nephropathy Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pain, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Rheumatic Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinico Universidad de Chile

Santiago, Metropolitan, 8380420, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous study drug

Drug

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

Intravenous saline solution

Other

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

Primary outcomes

  1. Morphine consumption

    Time frame: 24 hours

    Morphine consumed postoperatively during the first 24 hrs utilizing a patient-controlled analgesia device programmed 1mg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.

Secondary outcomes

  1. Basal quadriceps strength in the operative side

    Time frame: 1 hour before surgery

    Leg extension strength measured with a handheld dynamometer

  2. Basal level of pain during leg extension in the operative side

    Time frame: 1 hour before surgery

    Pain level measured with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  3. Basal plasmatic creatinine

    Time frame: 1 hour before surgery

    Plasmatic creatinine level measured in mg/dL from a blood sample

  4. Nerve block performance time

    Time frame: 5 minutes after anesthesia induction (before surgical incision)

    Time elapsed between skin disinfection and the end of local anesthetic injection in femoral triangle and posterior capsule blocks.

  5. Incidence of Block complications

    Time frame: 5 minutes after anesthesia induction and before surgical incision

    Report of vascular puncture, hematoma, local anesthetic systemic toxicity symptoms

  6. Time to first morphine dose request

    Time frame: 24 hours

    Time in minutes between arrival to post anesthesia care unit arrival and first request of morphine with the patient controlled analgesia device

  7. Morphine consumption during first 48 hours

    Time frame: 48 hours

    Morphine consumed postoperatively during the first 48 hrs utilizing a patient-controlled analgesia device programmed 0.01mg/Kg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.

  8. Incidence of opioid related side effects

    Time frame: 48 hours

    Report of nausea, vomitus, pruritus, urinary retention, respiratory depression

  9. Incidence of NSAIDs related clinical side effects

    Time frame: 48 hours

    Report of allergic reactions, pyrosis, evident gastrointestinal bleeding, hematoma

  10. Postoperative static pain level at 3 hours

    Time frame: 3 hours

    Pain level measured at rest with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  11. Postoperative dynamic pain level at 3 hours

    Time frame: 3 hours

    Pain level measured during leg extension with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  12. Postoperative static pain level at 6 hours

    Time frame: 6 hours

    Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  13. Postoperative dynamic pain level at 6 hours

    Time frame: 6 hours

    Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  14. Postoperative static pain level at 12 hours

    Time frame: 12 hours

    Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  15. Postoperative dynamic pain level at 12 hours

    Time frame: 12 hours

    Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  16. Postoperative static pain level at 24 hours

    Time frame: 24 hours

    Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  17. Postoperative dynamic pain level at 24 hours

    Time frame: 24 hours

    Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  18. Postoperative static pain level at 48 hours

    Time frame: 48 hours

    Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  19. Postoperative dynamic pain level at 48 hours

    Time frame: 48 hours

    Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)

  20. Medial malleolus sensory block level

    Time frame: 3 hours

    0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch

  21. Lateral malleolus sensory block level

    Time frame: 3hours

    0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch

  22. Medial malleolus sensory block level

    Time frame: 24 hours

    0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch

  23. Lateral malleolus sensory block level

    Time frame: 24 hours

    0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch

  24. Postoperative quadriceps strength

    Time frame: 3 hours

    Leg extension strength measured with a handheld dynamometer

  25. Postoperative quadriceps strength

    Time frame: 24 hours

    Leg extension strength measured with a handheld dynamometer

  26. Incidence of restriction to perform physiotherapy

    Time frame: 6 hours

    Inability to perform physiotherapy secondary to pain or motor blockade

  27. Incidence of restriction to perform physiotherapy

    Time frame: 24 hours

    Inability to perform physiotherapy secondary to pain or motor blockade

  28. Incidence of restriction to perform physiotherapy

    Time frame: 48 hours

    Inability to perform physiotherapy secondary to pain or motor blockade

  29. Postoperative plasmatic creatinine level

    Time frame: 48 hours

    Plasmatic creatinine level measured in mg/dL from a blood sample

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2023
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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