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

NCT06042426 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2306117408
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

TKA; Primary osteoarthritis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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)

Study Arms (2)

Patients receiving intravenous dexamethasone

EXPERIMENTAL

Drug: Dexamethasone

Patients receiving intravenous morphine and oral oxycodone

ACTIVE COMPARATOR

Drug: Morphine; Drug: Oxycodone and acetaminophen

Interventions

Dexamethasone DRUG

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

Patients receiving intravenous dexamethasone

Morphine DRUG

Morphine 0.1 mg per kg intravenous every 6 hours

Patients receiving intravenous morphine and oral oxycodone

Oxycodone and acetaminophen DRUG

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

Patients receiving intravenous morphine and oral oxycodone

Eligibility Criteria

• Age: 24 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

University of Puerto Ric-Dr. Federico Trilla Hospital

Carolina, 00984, Puerto Rico

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Dexamethasone; Morphine; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Study Officials

• Antonio M López Otero, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra M Claudio Marcano, MD

CONTACT

787-221-5210; alexandra.claudio1@upr.edu

Norberto J Torres, MD

CONTACT

787-403-8109; norberto.torres1@upr.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: September 18, 2023
• Study Start: September 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-08

Locations

PR (1)