NCT02219581

Steroids in Total Knee Arthroplasty

Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Thomas L Bradbury · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if the use of two small doses of intravenous (IV) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. The investigators will also determine if the subjects receiving the steroid will have better pain control and better postoperative outcomes after their surgery.

Detailed description

Adequate pain control after total knee arthroplasty (TKA) is of great importance not only to maximize patient comfort, but also to ensure optimal outcomes after surgery. This study is designed to assess whether the use of two small doses of intravenous (IV) steroids around the time of surgery decrease a patient's pain or use of pain medication. Secondly, the investigators will also determine if the use of these steroids as part of a multimodal pain management strategy leads to improved patient outcomes, including pain, nausea and vomiting, knee function and length of stay in the hospital after surgery. The study will compare the effect of two different doses of IV dexamethasone given preoperatively before TKA, when compared to placebo.

Conditions

• Postoperative Pain
• Inflammation
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Dexamethasone 10 mg	Two doses of dexamethasone 10 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
DRUG	Dexamethasone 20 mg	Two doses of dexamethasone 20 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
DRUG	Standard multimodal pain management regimen	The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following: Preoperative: * Decadron: 10 or 20mg IV x 1 2 doses, 8 hours apart (if randomized to study group) Intraoperative: * Ropivacaine: Given intraoperatively. Capsule, subcutaneous tissue/skin. Administered in standard fashion. (300mg) * Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. The dose is 15 mg for older patients or if creatinine clearance (CrCl) is low. Postoperative * Tylenol: 1000mg po q 8hr (scheduled) * Oxycodone: 5mg or 10mg q 3-4hr prn pain, If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid * IV Morphine (or Dilaudid): 1 or 2 mg q 2hr prn breakthrough pain * Morphine patient-controlled analgesia (PCA): only for failure of the above * Morphine Sulfate (MS) Contin: Use as backup prn pain
DRUG	Placebo	Participants in the placebo arm will receive two doses of saline intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.

Timeline

• Start date: 2014-10-16
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-08-19
• Last updated: 2022-10-04
• Results posted: 2022-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study