Dexamethasone in Total Knee Arthroplasty

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: Total Knee Arthroplasty
• Intervention / Treatment: Drug: Dexamethasone 4mg; Drug: Dexamethasone 8 Mg/mL Injectable Suspension; Drug: Dexamethasone 16mg

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): 438
• Phase: Phase 4

Contacts and Locations

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
    • St 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

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	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	assessed at days 1 through 7 after surgery, Day 7 reported
Postoperative Nausea	Using numeric rating scale, (0-10, where 10 is most nausea).	assessed at days 1 through 7 after surgery, Day 7 reported
Postoperative Blood Glucose Levels Without Diabetes	check glucose levels in blood draws the morning after surgery in mg/dL	Glucose levels taken the morning after surgery
Postoperative Blood Glucose Levels With Diabetes	check glucose levels, blood draws on morning after surgery measured in mg/dL	Glucose levels taken the morning after surgery
Number of Hours Slept Post Op Day 1	recorded by patient, reported number of hours slept each night for first week after surgery	Post op day 1, recording of hours slept
Number of Hours Slept Post Op Day 2	recorded by patient, reported number of hours slept each night for first week after surgery	Post op day 2, hours slept
Number of Hours Slept Post Op Day 3	recorded by patient, reported number of hours slept each night for first week after surgery	Post op day 3, hours slept
Number of Hours Slept Post Op Day 4	recorded by patient, reported number of hours slept each night for first week after surgery	Hours slept on POD 4
Number of Hours Slept Post Op Day 5	recorded by patient, reported number of hours slept each night for first week after surgery	Hours slept on POD 5
Number of Hours Slept Post Op Day 6	recorded by patient, reported number of hours slept each night for first week after surgery	Hours slept on POD 6
Number of Hours Slept Post Op Day 7	recorded by patient, reported number of hours slept each night for first week after surgery	Hours slept on POD 7
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	<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

• Sponsor: Rush University Medical Center

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

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, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: dexamethasone; postoperative pain; opioid consumption
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone
• 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