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

NCT ID: NCT06042426

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-02-29

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patients receiving intravenous dexamethasone

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Two 8 mg doses. One dose applied prior to incision and the other at POD1

Patients receiving intravenous morphine and oral oxycodone

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Morphine 0.1 mg per kg intravenous every 6 hours

Oxycodone and acetaminophen

Intervention Type: DRUG

2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)

Interventions

Dexamethasone

Two 8 mg doses. One dose applied prior to incision and the other at POD1

Intervention Type: DRUG

Morphine

Morphine 0.1 mg per kg intravenous every 6 hours

Intervention Type: DRUG

Oxycodone and acetaminophen

2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio M López Otero, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico

Locations

University of Puerto Ric-Dr. Federico Trilla Hospital

Carolina, , Puerto Rico

Countries

Puerto Rico

Central Contacts

Alexandra M Claudio Marcano, MD

Role: CONTACT

alexandra.claudio1@upr.edu

787-221-5210

Norberto J Torres, MD

Role: CONTACT

norberto.torres1@upr.edu

787-403-8109

Facility Contacts

Antonio M Otero López, MD

Role: primary

antonio.otero3@upr.edu

787-758-2525

Other Identifiers

2306117408

Identifier Type: -

Identifier Source: org_study_id