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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Dexamethasone; Drug: Morphine; Drug: Oxycodone and acetaminophen

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alexandra M Claudio Marcano, MD; Phone Number: 787-221-5210; Email: alexandra.claudio1@upr.edu
• Study Contact Backup: Name: Norberto J Torres, MD; Phone Number: 787-403-8109; Email: norberto.torres1@upr.edu

Study Locations

• Puerto Rico
  • Carolina, Puerto Rico, 00984
    • University of Puerto Ric-Dr. Federico Trilla Hospital
    • Contact: Antonio M Otero López, MD; Phone Number: 787-758-2525; Email: antonio.otero3@upr.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients receiving intravenous dexamethasone	Drug: Dexamethasone; Two 8 mg doses. One dose applied prior to incision and the other at POD1
Active Comparator: Patients receiving intravenous morphine and oral oxycodone	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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Puerto Rico
• Investigators: Principal Investigator: Antonio M López Otero, MD, Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: TKA; Primary osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antipyretics; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Analgesics, Opioid; Narcotics; Dexamethasone; Acetaminophen; Morphine; Oxycodone
• Other Study ID Numbers: 2306117408

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No