Dexamethasone in Total Knee Arthroplasty

July 31, 2025 updated by: Craig J Della Valle, MD, Rush University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Stanford University
      • San Francisco, California, United States, 94158
        • University of California, San Francisco
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Massachusetts
      • Somerville, Massachusetts, United States, 02145
        • Mass General Brigham
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Institutional Review
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Perelman School of Medicine
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Philadelphia University and Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Drug: Dexamethasone 4mg
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Other Names:
  • Group 1
Active Comparator: Group 2
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Drug: Dexamethasone 8 Mg/mL Injectable Suspension
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Other Names:
  • Group 2
Active Comparator: Group 3
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Drug: Dexamethasone 16mg
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Other Names:
  • Group 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 48-hours postoperative (after surgical intervention)
48 hours of cumulative opioid consumption measured in oral morphine equivalents
48-hours postoperative (after surgical intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores at rest and with activity
Time Frame: Immediately after surgical intervention (TKA) for days 1 through 7 after surgery
Using daily Defense and Veterans Pain Rating scale to rate pain at rest and with activity
Immediately after surgical intervention (TKA) for days 1 through 7 after surgery
Postoperative nausea and vomiting
Time Frame: Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale.
Using numeric rating scale, (1-10, where 10 is most nausea, causing vomiting followed by number of times participant vomited in 24-hour period).
Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale.
Postoperative Blood glucose levels and insulin use
Time Frame: Immediately following surgical intervention until discharge from hospital (up to 30 days after surgery if still in hospital)
check glucose levels in daily blood draws when inpatient at hospital, insulin if applicable
Immediately following surgical intervention until discharge from hospital (up to 30 days after surgery if still in hospital)
Length of stay
Time Frame: immediately following surgery (intervention), number of days spent in the hospital after surgery to discharge, up to 30 days after intervention
Days inpatient at hospital after surgery
immediately following surgery (intervention), number of days spent in the hospital after surgery to discharge, up to 30 days after intervention
Sleeplessness/insomnia
Time Frame: Immediately after surgical intervention (TKA) for days 1 through 7 after surgery, recording 24 hour sleep patterns
recorded by patient, daily sleep schedule
Immediately after surgical intervention (TKA) for days 1 through 7 after surgery, recording 24 hour sleep patterns
Number of participants with complications (such as readmission to hospital) 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
Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization
<30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2021

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21081102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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