Steroids in Total Knee Arthroplasty

Thomas L Bradbury

Status and phase: Terminated; Phase 4

Conditions: Postoperative Pain; Inflammation; Osteoarthritis

Treatments: Drug: Dexamethasone 20 mg; Drug: Standard multimodal pain management regimen; Drug: Placebo; Drug: Dexamethasone 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02219581

IRB00066081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing primary total joint arthroplasty of the knee
• Adult patients ages 18-100 years
• Patients must have smart phone and/or device for app usage

Exclusion criteria

• Current chronic steroid use
• Patients undergoing revision knee surgery
• Patients ambulating preoperatively with assistive devices
• Patients with avascular necrosis of the operative knee
• Patients with a history of an adverse reaction to glucocorticoid steroids
• Patients unable to provide informed consent
• Patients with inflammatory arthritis
• Prisoners
• Current smokers
• Patients <18 years of age
• Any patient with a complicated postoperative course that requires transfer to the Intensive Care Unit (ICU) or to another facility for further management will be removed from the study.
• Any contraindication that would prevent the patient from being treated with the standard multimodal postoperative pain management regimen History of infection of surgical knee.
• Patients with diabetes.
• Patients that have an intolerance to Toradol.
• Patients that do not have smart phone and/or device for app usage

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo 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.

Treatment:

Drug: Standard multimodal pain management regimen

Drug: Placebo

Dexamethasone 10 mg

Experimental group

Description:

Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. 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. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.

Treatment:

Drug: Dexamethasone 10 mg

Drug: Standard multimodal pain management regimen

Dexamethasone 20 mg

Experimental group

Description:

Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. 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. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.

Treatment:

Drug: Standard multimodal pain management regimen

Drug: Dexamethasone 20 mg