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

NCT06042426 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-18

No results posted yet for this study

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

Interventions

DRUG

Dexamethasone

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

DRUG

Morphine

Morphine 0.1 mg per kg intravenous every 6 hours

DRUG

Oxycodone and acetaminophen

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

Sponsors & Collaborators

  • University of Puerto Rico

    lead OTHER

Principal Investigators

  • Antonio M López Otero, MD · Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-02-29
Completion
2024-02-29
FDA Drug
Yes

Countries

  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06042426 on ClinicalTrials.gov