Steroids in Total Knee Arthroplasty

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.

Conditions

• Postoperative Pain
• Inflammation
• Osteoarthritis

Interventions

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.

Sponsors & Collaborators

• Thomas L Bradbury

  lead OTHER

Principal Investigators

• Thomas L Bradbury, MD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-16

Primary Completion

2015-12-01

Completion

2015-12-01

FDA Drug

Yes

Countries

• United States

Study Locations