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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06042426
• Other study ID #: 2306117408
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2023
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: University of Puerto Rico
• Contact: Alexandra M Claudio Marcano, MD
• Phone: 787-221-5210
• Email: alexandra.claudio1[@]upr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Ric-Dr. Federico Trilla Hospital	Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POD 1 Visual Analogue Scale Pain Scores	Range: 0-10 (10 indicates highest degree of pain)	Measured at 7:00AM day after surgery
Primary	POD 2 Visual Analogue Scale Pain Scores	Range: 0-10 (10 indicates highest degree of pain)	Measured at 7:00AM two days after surgery
Primary	POD 3 Visual Analogue Scale Pain Scores	Range: 0-10 (10 indicates highest degree of pain)	Measured at 7:00AM three days after surgery
Primary	POD 1 Range of Motion		Measured at 7:00AM the day after surgery
Primary	POD 2 Range of Motion		Measured at 7:00AM two days after surgery
Primary	POD 3 Range of Motion		Measured at 7:00AM three days after surgery
Secondary	Daily Dextrose Concentration (mg/dL)		Measured at 7:00AM for 3 days after surgery
Secondary	Length of Stay	Measured in days	From hospital admission to the date of discharge (About 3 days)