CClinicalTrials.gg
Sign In
CompletedNCT05018091Updated Aug 3, 2026Results posted

Dexamethasone in Total Knee Arthroplasty

A Phase 4 interventional study of Dexamethasone 4mg and Dexamethasone 8 Mg/mL Injectable Suspension in Total Knee Arthroplasty, sponsored by Rush University Medical Center. Completed at 10 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Rush University Medical Center · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
438
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Total Knee Arthroplasty

Browse trials for

Keywords

  • dexamethasone
  • opioid consumption
  • postoperative pain
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 438 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
438 participants (actual)

Study arms

  • Active comparator
    Group 1

    4mg intravenous dexamethasone, administered shortly after induction of anesthesia

    Drug: Dexamethasone 4mg

  • Active comparator
    Group 2

    8mg intravenous dexamethasone, administered shortly after induction of anesthesia

    Drug: Dexamethasone 8 Mg/mL Injectable Suspension

  • Active comparator
    Group 3

    16mg intravenous dexamethasone, administered shortly after induction of anesthesia

    Drug: Dexamethasone 16mg

Interventions

  • DrugDexamethasone 4mg

    4mg intravenous dexamethasone, administered shortly after induction of anesthesia

    Also known as: Group 1

  • DrugDexamethasone 8 Mg/mL Injectable Suspension

    8mg intravenous dexamethasone, administered shortly after induction of anesthesia

    Also known as: Group 2

  • DrugDexamethasone 16mg

    16mg intravenous dexamethasone, administered shortly after induction of anesthesia

    Also known as: Group 3

06

What researchers measure

Primary outcomes

  1. Opioid Consumption

    48 hours of cumulative opioid consumption measured in oral morphine equivalents

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

Secondary outcomes

  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

    Time frame: 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).

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    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

07

Results

Posted Aug 3, 2026
Limitations and caveats
RCT across 11 sites cannot be independently verified for all at each site. Postop antibiotic use was not systematically recorded. All patient-reported medications and outcomes are subject to inherent limitations of self-reported data. Study was powered to eval primary endpoint, may not be adequately powered to detect differences in other outcomes. Those with controlled diabetes mellitus (hgb A1c \<8.0%) were eligible; findings not generalizable to those with poor controlled diabetes mellitus.

Participant flow

Participant flow — Overall Study
MilestoneDexamethasone 4mgDexamethasone 8mgDexamethasone 16mg
Started146147145
Completed138137129
Not completed81016

Outcome measures

PrimaryOpioid Consumption

48 hours of cumulative opioid consumption measured in oral morphine equivalents

Time frame:
48-hours postoperative (after surgical intervention)
Reported as:
Mean · mg morphine equivalents
Opioid Consumption
mg morphine equivalentsGroup 1Group 2Group 3
Opioid Consumption101.0 ± 168.993.8 ± 122.372.8 ± 47.8
SecondaryPostoperative 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

Time frame:
assessed at days 1 through 7 after surgery, Day 7 reported
Reported as:
Mean · scores on a scale
Postoperative Pain Scores at Rest
scores on a scaleGroup 1Group 2Group 3
Postoperative Pain Scores at Rest3.7 ± 1.94.3 ± 2.03.8 ± 2.0
SecondaryPostoperative Nausea

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

Time frame:
assessed at days 1 through 7 after surgery, Day 7 reported
Reported as:
Mean · scores on a scale
Postoperative Nausea
scores on a scaleGroup 1Group 2Group 3
Postoperative Nausea0.46 ± 1.60.52 ± 2.50.07 ± 0.3
SecondaryPostoperative Blood Glucose Levels Without Diabetes

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

Time frame:
Glucose levels taken the morning after surgery
Reported as:
Mean · mg/dL
Postoperative Blood Glucose Levels Without Diabetes
mg/dLGroup 1Group 2Group 3
Postoperative Blood Glucose Levels Without Diabetes124.3 ± 23.6123.9 ± 28.2139.1 ± 39.5
SecondaryPostoperative Blood Glucose Levels With Diabetes

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

Time frame:
Glucose levels taken the morning after surgery
Reported as:
Mean · mg/dL
Postoperative Blood Glucose Levels With Diabetes
mg/dLGroup 1Group 2Group 3
Postoperative Blood Glucose Levels With Diabetes157.8 ± 40.5148.8 ± 49.8178.1 ± 48.1
SecondaryNumber of Hours Slept Post Op Day 1

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

Time frame:
Post op day 1, recording of hours slept
Reported as:
Mean · hours slept
Number of Hours Slept Post Op Day 1
hours sleptGroup 1Group 2Group 3
Number of Hours Slept Post Op Day 15.7 ± 2.55.4 ± 2.05.6 ± 2.1
SecondaryNumber of Hours Slept Post Op Day 2

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

Time frame:
Post op day 2, hours slept
Reported as:
Mean · hours slept
Number of Hours Slept Post Op Day 2
hours sleptGroup 1Group 2Group 3
Number of Hours Slept Post Op Day 26.5 ± 2.46.2 ± 2.06.0 ± 1.9
SecondaryNumber of Hours Slept Post Op Day 3

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

Time frame:
Post op day 3, hours slept
Reported as:
Mean · hours slept
Number of Hours Slept Post Op Day 3
hours sleptGroup 1Group 2Group 3
Number of Hours Slept Post Op Day 36.7 ± 2.06.6 ± 1.96.6 ± 1.9
SecondaryNumber of Hours Slept Post Op Day 4

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

Time frame:
Hours slept on POD 4
Reported as:
Mean · hours slept
Number of Hours Slept Post Op Day 4
hours sleptGroup 1Group 2Group 3
Number of Hours Slept Post Op Day 46.6 ± 2.26.6 ± 1.76.6 ± 2.1
SecondaryNumber of Hours Slept Post Op Day 5

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

Time frame:
Hours slept on POD 5
Reported as:
Mean · hours slept
Number of Hours Slept Post Op Day 5
hours sleptGroup 1Group 2Group 3
Number of Hours Slept Post Op Day 56.4 ± 2.06.6 ± 1.66.5 ± 2.1
SecondaryNumber of Hours Slept Post Op Day 6

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

Time frame:
Hours slept on POD 6
Reported as:
Mean · hours slept
Number of Hours Slept Post Op Day 6
hours sleptGroup 1Group 2Group 3
Number of Hours Slept Post Op Day 66.3 ± 2.06.3 ± 1.96.2 ± 2.1
SecondaryNumber of Hours Slept Post Op Day 7

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

Time frame:
Hours slept on POD 7
Reported as:
Mean · hours slept
Number of Hours Slept Post Op Day 7
hours sleptGroup 1Group 2Group 3
Number of Hours Slept Post Op Day 76.2 ± 1.96.4 ± 1.76.2 ± 2.0
SecondaryNumber 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

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
Reported as:
Count of participants · Participants
Number of Participants With Complications up to 30 Days After Surgical Intervention
ParticipantsGroup 1Group 2Group 3
Number of Participants With Complications up to 30 Days After Surgical Intervention557

Adverse events

Collected over Complications that occurred within 90-days after surgery were collected from all sites. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 10/138 (0%)2/138 (1.4%)3/138 (2.2%)
Group 20/137 (0%)1/137 (0.7%)1/137 (0.7%)
Group 30/129 (0%)3/129 (2.3%)3/129 (2.3%)
Most frequent serious events
Most frequent serious events
EventGroup 1Group 2Group 3
Manipulation under anesthesia for stiffness after total knee replacementMusculoskeletal and connective tissue disorders2/1381/1373/129
Most frequent other events
Most frequent other events
EventGroup 1Group 2Group 3
Aseptic Wound Complication following total knee replacementSkin and subcutaneous tissue disorders3/1381/1373/129

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group 1Group 2Group 3Total
Mean67.0 ± 8.867.4 ± 9.168.1 ± 8.967.5 ± 8.9
Sex: Female, Male
Sex: Female, Male(Participants)Group 1Group 2Group 3Total
Female897884251
Male495945153
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Group 1Group 2Group 3Total
Count of participants———0
08

Study locations

10 sites
  • Stanford University
    Redwood City, California 94063, United States
  • University of California, San Francisco
    San Francisco, California 94158, United States
  • Rush University medical Center
    Chicago, Illinois 60612, United States
  • Mass General Brigham
    Somerville, Massachusetts 02145, United States
  • Mayo Clinic Institutional Review
    Rochester, Minnesota 55902, United States
  • Washington University
    St Louis, Missouri 63110, United States
  • NYU Langone Health
    New York, New York 10016, United States
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
  • University of Pennsylvania Perelman School of Medicine
    Philadelphia, Pennsylvania 19104, United States
  • Jefferson Philadelphia University and Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
09

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 26, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05018091
Lead sponsor
Rush University Medical Center
Responsible party
Craig J Della Valle, MD (Professor of Orthopedic Surgery, Chief Division of Adult Reconstruction, Rush University Medical Center) — Principal investigator
First posted
Aug 24, 2021
Start date
Oct 28, 2021
Primary completion
Jan 1, 2025
Completion
May 30, 2025
Results posted
Aug 3, 2026
Last update
Aug 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pain, Postoperative→

Other studies from this sponsor

Rush University Medical Center

Start the discussion