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

University of Puerto Rico (UPR)

Status and phase: Not yet enrolling; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: Dexamethasone; Drug: Oxycodone and acetaminophen; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06042426

2306117408

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 24+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Patients receiving intravenous dexamethasone

Experimental group

Treatment:

Drug: Dexamethasone

Patients receiving intravenous morphine and oral oxycodone

Active Comparator group

Treatment:

Drug: Oxycodone and acetaminophen

Drug: Morphine