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Total Knee ArthroplastyPhase 4NCT05018091

Dexamethasone in Total Knee Arthroplasty

A Phase 4 study testing Dexamethasone 4mg, Dexamethasone 8 Mg/mL Injectable Suspension and Dexamethasone 16mg in people with Total Knee Arthroplasty, run by Rush University Medical Center at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Total Knee Arthroplasty
What is being tested?
Dexamethasone 4mg, Dexamethasone 8 Mg/mL Injectable Suspension and Dexamethasone 16mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
438 participants
Where
10 sitesUnited States
Study dates
28 Oct 2021to 30 May 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Rush University medical Center

    Chicago, Illinois, 60612

  • NYU Langone Health

    New York, New York, 10016

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104

  • Jefferson Philadelphia University and Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Stanford University

    Redwood City, California, 94063

  • Mayo Clinic Institutional Review

    Rochester, Minnesota, 55902

  • University of California, San Francisco

    San Francisco, California, 94158

  • Mass General Brigham

    Somerville, Massachusetts, 02145

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Dexamethasone 4mg, Dexamethasone 8 Mg/mL Injectable Suspension, Dexamethasone 16mg
Keywords
dexamethasone, opioid consumption, postoperative pain
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone 4mgDrug

    Also called Group 1

    4mg intravenous dexamethasone, administered shortly after induction of anesthesia

  • Dexamethasone 8 Mg/mL Injectable SuspensionDrug

    Also called Group 2

    8mg intravenous dexamethasone, administered shortly after induction of anesthesia

  • Dexamethasone 16mgDrug

    Also called Group 3

    16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Study groups in NCT05018091
Study groupRoleWhat they receive
Group 1Active comparator4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Receives: Drug: Dexamethasone 4mg
Group 2Active comparator8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Receives: Drug: Dexamethasone 8 Mg/mL Injectable Suspension
Group 3Active comparator16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Receives: Drug: Dexamethasone 16mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid Consumption

    48 hours of cumulative opioid consumption measured in oral morphine equivalents

    Measured: 48-hours postoperative (after surgical intervention)

Secondary outcomes (12)

  1. Postoperative Pain Scores at Rest

    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

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

  2. Postoperative Nausea

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

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

  3. Postoperative Blood Glucose Levels Without Diabetes

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

    Measured: Glucose levels taken the morning after surgery

  4. Postoperative Blood Glucose Levels With Diabetes

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

    Measured: Glucose levels taken the morning after surgery

  5. Number of Hours Slept Post Op Day 1

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

    Measured: Post op day 1, recording of hours slept

  6. Number of Hours Slept Post Op Day 2

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

    Measured: Post op day 2, hours slept

  7. Number of Hours Slept Post Op Day 3

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

    Measured: Post op day 3, hours slept

  8. Number of Hours Slept Post Op Day 4

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

    Measured: Hours slept on POD 4

  9. Number of Hours Slept Post Op Day 5

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

    Measured: Hours slept on POD 5

  10. Number of Hours Slept Post Op Day 6

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

    Measured: Hours slept on POD 6

  11. Number of Hours Slept Post Op Day 7

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

    Measured: Hours slept on POD 7

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start28 Oct 2021
  3. Primary completion1 Jan 2025
  4. Study completion30 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05018091
Sponsor's protocol ID
21081102
Status last verified
Jul 2026
First submitted
12 Aug 2021
Last updated
3 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moucha CS, Weiser MC, Levin EJ. Current Strategies in Anesthesia and Analgesia for Total Knee Arthroplasty. J Am Acad Orthop Surg. 2016 Feb;24(2):60-73. doi: 10.5435/JAAOS-D-14-00259.

    PubMed 26803543

  • Hannon CP, Keating TC, Lange JK, Ricciardi BF, Waddell BS, Della Valle CJ. Anesthesia and Analgesia Practices in Total Joint Arthroplasty: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2019 Dec;34(12):2872-2877.e2. doi: 10.1016/j.arth.2019.06.055. Epub 2019 Jul 8.

    PubMed 31371038

  • Parvizi J, Miller AG, Gandhi K. Multimodal pain management after total joint arthroplasty. J Bone Joint Surg Am. 2011 Jun 1;93(11):1075-84. doi: 10.2106/JBJS.J.01095.

    PubMed 21655901

  • Lex JR, Edwards TC, Packer TW, Jones GG, Ravi B. Perioperative Systemic Dexamethasone Reduces Length of Stay in Total Joint Arthroplasty: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Arthroplasty. 2021 Mar;36(3):1168-1186. doi: 10.1016/j.arth.2020.10.010. Epub 2020 Oct 16.

    PubMed 33190999

  • Lunn TH, Kehlet H. Perioperative glucocorticoids in hip and knee surgery - benefit vs. harm? A review of randomized clinical trials. Acta Anaesthesiol Scand. 2013 Aug;57(7):823-34. doi: 10.1111/aas.12115. Epub 2013 Apr 15.

    PubMed 23581549

  • Chen P, Li X, Sang L, Huang J. Perioperative intravenous glucocorticoids can decrease postoperative nausea and vomiting and pain in total joint arthroplasty: A meta-analysis and trial sequence analysis. Medicine (Baltimore). 2017 Mar;96(13):e6382. doi: 10.1097/MD.0000000000006382.

    PubMed 28353565

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone 4mg, Dexamethasone 8 Mg/mL Injectable Suspension and Dexamethasone 16mg in people with Total Knee Arthroplasty, run by Rush University Medical Center at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Consumption (time frame: 48-hours postoperative (after surgical intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05018091, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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