Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Thomas Vail
Headshot of Thomas Vail
Thomas Vail

Description

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.

Official Title

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

Details

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.

Keywords

Total Knee Arthroplasty dexamethasone opioid consumption postoperative pain Dexamethasone acetate BB 1101 Dexamethasone 4mg Dexamethasone 8 Mg/mL Injectable Suspension Dexamethasone 16mg

Eligibility

You can join if…

Open to people ages 18 years and up

You CAN'T join 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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States
  • Shiley Center for Orthopaedic Research and Education at Scripps Clinic accepting new patients
    La Jolla California 92037 United States

Lead Scientist at UCSF

  • Thomas Vail
    Dr. Vail is the Michael and Antoinette Pappas Endowed Chair of the Department of Orthopaedic Surgery at the University of California, San Francisco. He graduated from the Duke University School of Engineering cum laude with a degree in Mechanical Engineering and Materials Science, and earned his medical degree at the Stritch School of Medicine at Loyola University, Chicago.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rush University Medical Center
ID
NCT05018091
Phase
Phase 4 Knee Replacement Research Study
Study Type
Interventional
Participants
Expecting 429 study participants
Last Updated