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NCT Number: NCT05018091

Dexamethasone in Total Knee Arthroplasty

The purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University, Redwood City, California, United States

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About this study

Study design: Prospective randomized controlled trial

Scientific Background: In contemporary total joint arthroplasty (TJA), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 Multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. Corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols.

Corticosteroids are frequently used in TJA due to their potent anti-inflammatory and anti-emetic properties. Several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 However, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. In addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. Thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during TJA.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18 years
  • Primary total knee arthroplasty
  • Patients staying at least one night in the hospital after surgery

Exclusion criteria

  • Same day discharge Age < 18 years Revision or partial total knee arthroplasty Corticosteroid use within 3 months prior to surgery Inflammatory arthritis Current systemic fungal infection Renal or liver failure Prior adverse reaction to corticosteroid Primary TKA requiring hardware removal

Treatment and study plan

Dexamethasone 4mg

Drug

4mg intravenous dexamethasone, administered shortly after induction of anesthesia

Other names: Group 1

Dexamethasone 8 Mg/mL Injectable Suspension

Drug

8mg intravenous dexamethasone, administered shortly after induction of anesthesia

Other names: Group 2

Dexamethasone 16mg

Drug

16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Other names: Group 3

Primary outcomes

  1. Opioid Consumption

    Time frame: 48-hours postoperative (after surgical intervention)

    48 hours of cumulative opioid consumption measured in oral morphine equivalents

Secondary outcomes

  1. Postoperative Pain Scores at Rest

    Time frame: assessed at days 1 through 7 after surgery, Day 7 reported

    Using daily Defense and Veterans Pain Rating scale (VPRS) to rate pain at rest, on a scale of 0-10 where 0 means no pain and 10 is the highest pain

  2. Postoperative Nausea

    Time frame: assessed at days 1 through 7 after surgery, Day 7 reported

    Using numeric rating scale, (0-10, where 10 is most nausea).

  3. Postoperative Blood Glucose Levels Without Diabetes

    Time frame: Glucose levels taken the morning after surgery

    check glucose levels in blood draws the morning after surgery in mg/dL

  4. Postoperative Blood Glucose Levels With Diabetes

    Time frame: Glucose levels taken the morning after surgery

    check glucose levels, blood draws on morning after surgery measured in mg/dL

  5. Number of Hours Slept Post Op Day 1

    Time frame: Post op day 1, recording of hours slept

    recorded by patient, reported number of hours slept each night for first week after surgery

  6. Number of Hours Slept Post Op Day 2

    Time frame: Post op day 2, hours slept

    recorded by patient, reported number of hours slept each night for first week after surgery

  7. Number of Hours Slept Post Op Day 3

    Time frame: Post op day 3, hours slept

    recorded by patient, reported number of hours slept each night for first week after surgery

  8. Number of Hours Slept Post Op Day 4

    Time frame: Hours slept on POD 4

    recorded by patient, reported number of hours slept each night for first week after surgery

  9. Number of Hours Slept Post Op Day 5

    Time frame: Hours slept on POD 5

    recorded by patient, reported number of hours slept each night for first week after surgery

  10. Number of Hours Slept Post Op Day 6

    Time frame: Hours slept on POD 6

    recorded by patient, reported number of hours slept each night for first week after surgery

  11. Number of Hours Slept Post Op Day 7

    Time frame: Hours slept on POD 7

    recorded by patient, reported number of hours slept each night for first week after surgery

  12. Number of Participants With Complications up to 30 Days After Surgical Intervention

    Time frame: <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery

    Complications and Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2021
Registry last updated
Aug 3, 2026

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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