Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Dexamethasone
- Conditions
- Osteoarthritis, Knee
- Sponsor
- University of Puerto Rico
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- POD 1 Visual Analogue Scale Pain Scores
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with Hispanic self-identification
- •Primary robotic-assisted TKA for treatment of primary osteoarthritis
- •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
- •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.
Arms & Interventions
Patients receiving intravenous dexamethasone
Intervention: Dexamethasone
Patients receiving intravenous morphine and oral oxycodone
Intervention: Morphine
Patients receiving intravenous morphine and oral oxycodone
Intervention: Oxycodone and acetaminophen
Outcomes
Primary Outcomes
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 Outcomes
- Daily Dextrose Concentration (mg/dL)(Measured at 7:00AM for 3 days after surgery)
- Length of Stay(From hospital admission to the date of discharge (About 3 days))