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

Overview

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.

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Investigator)
• Study Primary Completion Date: February 2024

Interventions

• 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)

Arms, Groups and Cohorts

• Experimental: Patients receiving intravenous dexamethasone
• Active Comparator: Patients receiving intravenous morphine and oral oxycodone

Clinical Trial Outcome Measures

Primary Measures

• POD 1 Visual Analogue Scale Pain Scores
  • Time Frame: Measured at 7:00AM day after surgery
  • Range: 0-10 (10 indicates highest degree of pain)
• POD 2 Visual Analogue Scale Pain Scores
  • Time Frame: Measured at 7:00AM two days after surgery
  • Range: 0-10 (10 indicates highest degree of pain)
• POD 3 Visual Analogue Scale Pain Scores
  • Time Frame: Measured at 7:00AM three days after surgery
  • Range: 0-10 (10 indicates highest degree of pain)
• POD 1 Range of Motion
  • Time Frame: Measured at 7:00AM the day after surgery
• POD 2 Range of Motion
  • Time Frame: Measured at 7:00AM two days after surgery
• POD 3 Range of Motion
  • Time Frame: Measured at 7:00AM three days after surgery

Secondary Measures

• Daily Dextrose Concentration (mg/dL)
  • Time Frame: Measured at 7:00AM for 3 days after surgery
• Length of Stay
  • Time Frame: From hospital admission to the date of discharge (About 3 days)
  • Measured in days

Participating in This Clinical Trial

Inclusion Criteria

• Patient with Hispanic self-identification – Primary robotic-assisted TKA for treatment of primary osteoarthritis – Age ≥ 21 – Receiving seven days of inpatient rehabilitation after medical discharge – Patient with adequate glycemic control (HbA1c<7.5%) – Patients who provide written informed consent Exclusion Criteria:

• Age ≤ 21 – Chronic steroid use prior to surgery – Previous allergies or adverse reactions to steroid drugs – Indications for surgery other than primary osteoarthritis – History of narcotics abuse such as opioids – Surgeries performed without robotic-assistance – Outpatient or Home rehabilitation programs after medical discharge – Requirement of revision surgery orthopaedic implants – Patients with inadequate glycemic control (HbA1c≥7.5%) – Other medical conditions, such as osteoporosis, fungal infections, glaucoma, joint infections, peptic ulcer disease which could worsen with steroid administration.

Gender Eligibility: All

Minimum Age: 24 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Puerto Rico
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Antonio M López Otero, MD, Principal Investigator, Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
• Overall Contact(s)
  • Alexandra M Claudio Marcano, MD, 787-221-5210, alexandra.claudio1@upr.edu