Dexamethasone in Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05018091
• Other study ID #: 21081102
• Status: Recruiting
• Phase: Phase 4
• Start date: October 28, 2021
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Rush University Medical Center
• Contact: Anne DeBenedetti, BA
• Phone: 3124322468
• Email: anne.debenedetti[@]rushortho.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 429
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Rush University medical Center	Chicago	Illinois
United States	Columbia University Irving Medical Center	New York	New York
United States	NYU Langone Health	New York	New York
United States	Jefferson Philadelphia University and Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania
United States	Stanford University	Redwood City	California
United States	Mayo Clinic Institutional Review	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California
United States	Mass General Brigham	Somerville	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	48 hours of cumulative opioid consumption measured in oral morphine equivalents	48-hours postoperative (after surgical intervention)
Secondary	Postoperative pain scores at rest and with activity	Using daily Defense and Veterans Pain Rating scale to rate pain at rest and with activity	Immediately after surgical intervention (TKA) for days 1 through 7 after surgery
Secondary	Postoperative nausea and vomiting	Using numeric rating scale, (1-10, where 10 is most nausea, causing vomiting followed by number of times participant vomited in 24-hour period).	Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale.
Secondary	Postoperative Blood glucose levels and insulin use	check glucose levels in daily blood draws when inpatient at hospital, insulin if applicable	Immediately following surgical intervention until discharge from hospital (up to 30 days after surgery if still in hospital)
Secondary	Length of stay	Days inpatient at hospital after surgery	immediately following surgery (intervention), number of days spent in the hospital after surgery to discharge, up to 30 days after intervention
Secondary	Sleeplessness/insomnia	recorded by patient, daily sleep schedule	Immediately after surgical intervention (TKA) for days 1 through 7 after surgery, recording 24 hour sleep patterns
Secondary	Number of participants with complications (such as readmission to hospital) up to 30 days after surgical intervention	Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization	<30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery