Total Knee Arthroplasty Clinical Trial
Official title:
Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively
Verified date | June 2024 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 404 |
Est. completion date | October 2024 |
Est. primary completion date | August 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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
United States,
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
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 |
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