Study Results
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Basic Information
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COMPLETED
PHASE4
404 participants
INTERVENTIONAL
2021-10-28
2025-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group 1
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Group 2
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Group 3
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Interventions
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Dexamethasone 4mg
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary total knee arthroplasty
* Patients staying at least one night in the hospital after surgery
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Rush University Medical Center
OTHER
Responsible Party
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Craig J Della Valle, MD
Professor of Orthopedic Surgery, Chief Division of Adult Reconstruction
Locations
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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
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
Countries
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References
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Moucha CS, Weiser MC, Levin EJ. Current Strategies in Anesthesia and Analgesia for Total Knee Arthroplasty. J Am Acad Orthop Surg. 2016 Feb;24(2):60-73. doi: 10.5435/JAAOS-D-14-00259.
Hannon CP, Keating TC, Lange JK, Ricciardi BF, Waddell BS, Della Valle CJ. Anesthesia and Analgesia Practices in Total Joint Arthroplasty: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2019 Dec;34(12):2872-2877.e2. doi: 10.1016/j.arth.2019.06.055. Epub 2019 Jul 8.
Parvizi J, Miller AG, Gandhi K. Multimodal pain management after total joint arthroplasty. J Bone Joint Surg Am. 2011 Jun 1;93(11):1075-84. doi: 10.2106/JBJS.J.01095.
Lex JR, Edwards TC, Packer TW, Jones GG, Ravi B. Perioperative Systemic Dexamethasone Reduces Length of Stay in Total Joint Arthroplasty: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Arthroplasty. 2021 Mar;36(3):1168-1186. doi: 10.1016/j.arth.2020.10.010. Epub 2020 Oct 16.
Lunn TH, Kehlet H. Perioperative glucocorticoids in hip and knee surgery - benefit vs. harm? A review of randomized clinical trials. Acta Anaesthesiol Scand. 2013 Aug;57(7):823-34. doi: 10.1111/aas.12115. Epub 2013 Apr 15.
Chen P, Li X, Sang L, Huang J. Perioperative intravenous glucocorticoids can decrease postoperative nausea and vomiting and pain in total joint arthroplasty: A meta-analysis and trial sequence analysis. Medicine (Baltimore). 2017 Mar;96(13):e6382. doi: 10.1097/MD.0000000000006382.
Other Identifiers
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21081102
Identifier Type: -
Identifier Source: org_study_id
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