NCT06042426

Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population

Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Puerto Rico · Academic / Other
• Sex: All
• Age: 24 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to opioid-based pain treatment following TKA. The study hopefully validates the use of a two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied prior to incision and the other at post-operative day (POD) 1.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Dexamethasone	Two 8 mg doses. One dose applied prior to incision and the other at POD1
DRUG	Morphine	Morphine 0.1 mg per kg intravenous every 6 hours
DRUG	Oxycodone and acetaminophen	2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-09-18
• Last updated: 2023-09-18

Locations

1 site across 1 country: Puerto Rico

Regulatory

• FDA-regulated drug study