Dexamethasone in Total Knee Arthroplasty

NCT05018091 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21081102
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Total Knee Arthroplasty

Keywords

dexamethasone; opioid consumption; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  48 hours of cumulative opioid consumption measured in oral morphine equivalents

  48-hours postoperative (after surgical intervention)

Secondary Outcomes (12)

• Postoperative Pain Scores at Rest

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

• Postoperative Nausea

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

• Postoperative Blood Glucose Levels Without Diabetes

  Glucose levels taken the morning after surgery

• Postoperative Blood Glucose Levels With Diabetes

  Glucose levels taken the morning after surgery

• Number of Hours Slept Post Op Day 1

  Post op day 1, recording of hours slept

Study Arms (3)

Group 1

ACTIVE COMPARATOR

4mg intravenous dexamethasone, administered shortly after induction of anesthesia

Drug: Dexamethasone 4mg

Group 2

ACTIVE COMPARATOR

8mg intravenous dexamethasone, administered shortly after induction of anesthesia

Drug: Dexamethasone 8 Mg/mL Injectable Suspension

Group 3

ACTIVE COMPARATOR

16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Drug: Dexamethasone 16mg

Interventions

Dexamethasone 4mg DRUG

4mg intravenous dexamethasone, administered shortly after induction of anesthesia

Also known as: Group 1

Group 1

Dexamethasone 8 Mg/mL Injectable Suspension DRUG

8mg intravenous dexamethasone, administered shortly after induction of anesthesia

Also known as: Group 2

Group 2

Dexamethasone 16mg DRUG

16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Also known as: Group 3

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (10)

Stanford University

Redwood City, California, 94063, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Rush University medical Center

Chicago, Illinois, 60612, United States

Location

Mass General Brigham

Somerville, Massachusetts, 02145, United States

Location

Mayo Clinic Institutional Review

Rochester, Minnesota, 55902, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson Philadelphia University and Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (6)

• 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.

  PMID: 26803543 BACKGROUND

• 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.

  PMID: 31371038 BACKGROUND

• 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.

  PMID: 21655901 BACKGROUND

• 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.

  PMID: 33190999 BACKGROUND

• 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.

  PMID: 23581549 BACKGROUND

• 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.

  PMID: 28353565 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

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.

Results Point of Contact

• Title: What is the Safest and Most Effective Dose of IV Dexamethasone in TKA? A Multicenter Randomized Cont
• Organization: Rush University Medical Center

anne.debenedetti@rushortho.com

3124322468

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedic Surgery, Chief Division of Adult Reconstruction

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 24, 2021
• Study Start: October 28, 2021
• Primary Completion: January 1, 2025
• Study Completion: May 30, 2025
• Last Updated: August 3, 2026
• Results First Posted: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)