NCT05018091

Dexamethasone in Total Knee Arthroplasty

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DRUG	Dexamethasone 4mg	4mg intravenous dexamethasone, administered shortly after induction of anesthesia
DRUG	Dexamethasone 8 Mg/mL Injectable Suspension	8mg intravenous dexamethasone, administered shortly after induction of anesthesia
DRUG	Dexamethasone 16mg	16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Timeline

• Start date: 2021-10-28
• Primary completion: 2025-01-01
• Completion: 2025-05-30
• First posted: 2021-08-24
• Last updated: 2025-08-03

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study