Dexamethasone in Total Knee Arthroplasty
- Conditions
- Total Knee Arthroplasty
- Interventions
- Registration Number
- NCT05018091
- Lead Sponsor
- Rush University Medical Center
- Brief Summary
The purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.
- Detailed Description
Study design: Prospective randomized controlled trial
Scientific Background: In contemporary total joint arthroplasty (TJA), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 Multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. Corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols.
Corticosteroids are frequently used in TJA due to their potent anti-inflammatory and anti-emetic properties. Several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 However, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. In addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. Thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during TJA.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 404
- Age > 18 years
- Primary total knee arthroplasty
- Patients staying at least one night in the hospital after surgery
- Same day discharge Age < 18 years Revision or partial total knee arthroplasty Corticosteroid use within 3 months prior to surgery Inflammatory arthritis Current systemic fungal infection Renal or liver failure Prior adverse reaction to corticosteroid Primary TKA requiring hardware removal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Dexamethasone 8 Mg/mL Injectable Suspension 8mg intravenous dexamethasone, administered shortly after induction of anesthesia Group 3 Dexamethasone 16mg 16mg intravenous dexamethasone, administered shortly after induction of anesthesia Group 1 Dexamethasone 4mg 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
- Primary Outcome Measures
Name Time Method Opioid consumption 48-hours postoperative (after surgical intervention) 48 hours of cumulative opioid consumption measured in oral morphine equivalents
- Secondary Outcome Measures
Name Time Method Postoperative pain scores at rest and with activity Immediately after surgical intervention (TKA) for days 1 through 7 after surgery Using daily Defense and Veterans Pain Rating scale to rate pain at rest and with activity
Postoperative nausea and vomiting Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale. Using numeric rating scale, (1-10, where 10 is most nausea, causing vomiting followed by number of times participant vomited in 24-hour period).
Postoperative Blood glucose levels and insulin use Immediately following surgical intervention until discharge from hospital (up to 30 days after surgery if still in hospital) check glucose levels in daily blood draws when inpatient at hospital, insulin if applicable
Length of stay immediately following surgery (intervention), number of days spent in the hospital after surgery to discharge, up to 30 days after intervention Days inpatient at hospital after surgery
Sleeplessness/insomnia Immediately after surgical intervention (TKA) for days 1 through 7 after surgery, recording 24 hour sleep patterns recorded by patient, daily sleep schedule
Number of participants with complications (such as readmission to hospital) up to 30 days after surgical intervention <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization
Trial Locations
- Locations (10)
Stanford University
🇺🇸Redwood City, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Rush University medical Center
🇺🇸Chicago, Illinois, United States
Mass General Brigham
🇺🇸Somerville, Massachusetts, United States
Mayo Clinic Institutional Review
🇺🇸Rochester, Minnesota, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
NYU Langone Health
🇺🇸New York, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
University of Pennsylvania Perelman School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Jefferson Philadelphia University and Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States