Back to resultsEffects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
Primary Purpose
Osteoarthritis, Knee
Status
Not yet recruiting
Phase
Phase 4
Locations
Puerto Rico
Study Type
Interventional
Intervention
Dexamethasone
Morphine
Oxycodone and acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring TKA, Primary osteoarthritis
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.
Sites / Locations
- University of Puerto Ric-Dr. Federico Trilla Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients receiving intravenous dexamethasone
Patients receiving intravenous morphine and oral oxycodone
Arm Description
Outcomes
Primary Outcome Measures
POD 1 Visual Analogue Scale Pain Scores
Range: 0-10 (10 indicates highest degree of pain)
POD 2 Visual Analogue Scale Pain Scores
Range: 0-10 (10 indicates highest degree of pain)
POD 3 Visual Analogue Scale Pain Scores
Range: 0-10 (10 indicates highest degree of pain)
POD 1 Range of Motion
POD 2 Range of Motion
POD 3 Range of Motion
Secondary Outcome Measures
Daily Dextrose Concentration (mg/dL)
Length of Stay
Measured in days
Full Information
NCT ID
NCT06042426
First Posted
August 3, 2023
Last Updated
September 13, 2023
Sponsor
University of Puerto Rico
1. Study Identification
Unique Protocol Identification Number
NCT06042426
Brief Title
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
Official Title
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Puerto Rico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
TKA, Primary osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients receiving intravenous dexamethasone
Arm Type
Experimental
Arm Title
Patients receiving intravenous morphine and oral oxycodone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Two 8 mg doses. One dose applied prior to incision and the other at POD1
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine 0.1 mg per kg intravenous every 6 hours
Intervention Type
Drug
Intervention Name(s)
Oxycodone and acetaminophen
Intervention Description
2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)
Primary Outcome Measure Information:
Title
POD 1 Visual Analogue Scale Pain Scores
Description
Range: 0-10 (10 indicates highest degree of pain)
Time Frame
Measured at 7:00AM day after surgery
Title
POD 2 Visual Analogue Scale Pain Scores
Description
Range: 0-10 (10 indicates highest degree of pain)
Time Frame
Measured at 7:00AM two days after surgery
Title
POD 3 Visual Analogue Scale Pain Scores
Description
Range: 0-10 (10 indicates highest degree of pain)
Time Frame
Measured at 7:00AM three days after surgery
Title
POD 1 Range of Motion
Time Frame
Measured at 7:00AM the day after surgery
Title
POD 2 Range of Motion
Time Frame
Measured at 7:00AM two days after surgery
Title
POD 3 Range of Motion
Time Frame
Measured at 7:00AM three days after surgery
Secondary Outcome Measure Information:
Title
Daily Dextrose Concentration (mg/dL)
Time Frame
Measured at 7:00AM for 3 days after surgery
Title
Length of Stay
Description
Measured in days
Time Frame
From hospital admission to the date of discharge (About 3 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra M Claudio Marcano, MD
Phone
787-221-5210
Email
alexandra.claudio1@upr.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Norberto J Torres, MD
Phone
787-403-8109
Email
norberto.torres1@upr.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio M López Otero, MD
Organizational Affiliation
Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Puerto Ric-Dr. Federico Trilla Hospital
City
Carolina
ZIP/Postal Code
00984
Country
Puerto Rico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio M Otero López, MD
Phone
787-758-2525
Email
antonio.otero3@upr.edu
12. IPD Sharing Statement
Learn more about this trial
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
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