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

Phase 4

Not yet recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Dexamethasone; Drug: Morphine; Drug: Oxycodone and acetaminophen

• Registration Number: NCT06042426
• Lead Sponsor: University of Puerto Rico

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-03
• Study Start: 2023-09
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receiving intravenous dexamethasone	Dexamethasone	-
Patients receiving intravenous morphine and oral oxycodone	Morphine	-
Patients receiving intravenous morphine and oral oxycodone	Oxycodone and acetaminophen	-

Primary Outcome Measures

Name	Time	Method
POD 1 Visual Analogue Scale Pain Scores	Measured at 7:00AM day after surgery	Range: 0-10 (10 indicates highest degree of pain)
POD 2 Visual Analogue Scale Pain Scores	Measured at 7:00AM two days after surgery	Range: 0-10 (10 indicates highest degree of pain)
POD 3 Visual Analogue Scale Pain Scores	Measured at 7:00AM three days after surgery	Range: 0-10 (10 indicates highest degree of pain)
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 Outcome Measures

Name	Time	Method
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)	Measured in days

Trial Locations

Locations (1)

University of Puerto Ric-Dr. Federico Trilla Hospital; 🇵🇷 Carolina, Puerto Rico