Clinical trial NCT05018091: Dexamethasone in Total Knee Arthroplasty
Official title: Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Keywords: dexamethasone
opioid consumption
postoperative pain
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Primary total knee arthroplasty
* Patients staying at least one night in the hospital after surgery

Exclusion Criteria:

* 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

Primary outcomes:
measure: Opioid consumption
timeFrame: 48-hours postoperative (after surgical intervention)
Secondary outcomes:
measure: Postoperative pain scores at rest and with activity
timeFrame: Immediately after surgical intervention (TKA) for days 1 through 7 after surgery
measure: Postoperative nausea and vomiting
timeFrame: Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale.
measure: Postoperative Blood glucose levels and insulin use
timeFrame: Immediately following surgical intervention until discharge from hospital (up to 30 days after surgery if still in hospital)
measure: Length of stay
timeFrame: immediately following surgery (intervention), number of days spent in the hospital after surgery to discharge, up to 30 days after intervention
measure: Sleeplessness/insomnia
timeFrame: Immediately after surgical intervention (TKA) for days 1 through 7 after surgery, recording 24 hour sleep patterns
measure: Number of participants with complications (such as readmission to hospital) up to 30 days after surgical intervention
timeFrame: <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: Rush University medical Center
state: Illinois
city: Somerville
country: United States
facility: Mass General Brigham
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Institutional Review
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Philadelphia University and Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.