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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
438
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
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
Opioid Consumption
48 hours of cumulative opioid consumption measured in oral morphine equivalents
Time frame: 48-hours postoperative (after surgical intervention)
Postoperative Pain Scores at Rest
Using daily Defense and Veterans Pain Rating scale (VPRS) to rate pain at rest, on a scale of 0-10 where 0 means no pain and 10 is the highest pain
Time frame: assessed at days 1 through 7 after surgery, Day 7 reported
Postoperative Nausea
Using numeric rating scale, (0-10, where 10 is most nausea).
Time frame: assessed at days 1 through 7 after surgery, Day 7 reported
Postoperative Blood Glucose Levels Without Diabetes
check glucose levels in blood draws the morning after surgery in mg/dL
Time frame: Glucose levels taken the morning after surgery
Postoperative Blood Glucose Levels With Diabetes
check glucose levels, blood draws on morning after surgery measured in mg/dL
Time frame: Glucose levels taken the morning after surgery
Number of Hours Slept Post Op Day 1
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Post op day 1, recording of hours slept
Number of Hours Slept Post Op Day 2
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Post op day 2, hours slept
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Mass General Brigham
Somerville, Massachusetts, United States
Mayo Clinic Institutional Review
Rochester, Minnesota, United States
Washington University
St 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
Number of Hours Slept Post Op Day 3
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Post op day 3, hours slept
Number of Hours Slept Post Op Day 4
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Hours slept on POD 4
Number of Hours Slept Post Op Day 5
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Hours slept on POD 5
Number of Hours Slept Post Op Day 6
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Hours slept on POD 6
Number of Hours Slept Post Op Day 7
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Hours slept on POD 7
Number of Participants With Complications up to 30 Days After Surgical Intervention
Complications and Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization
Time frame: <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery