Steroids in Total Knee Arthroplasty

NCT ID: NCT02219581

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-16
• Study Completion Date: 2015-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Standard multimodal pain management regimen

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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.

Dexamethasone 10 mg

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.

Group Type: EXPERIMENTAL

Dexamethasone 10 mg

Intervention Type: DRUG

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.

Standard multimodal pain management regimen

Intervention Type: DRUG

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

Dexamethasone 20 mg

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.

Group Type: EXPERIMENTAL

Dexamethasone 20 mg

Intervention Type: DRUG

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.

Standard multimodal pain management regimen

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Decadron; Decadron

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas L Bradbury

OTHER

Sponsor Role: lead

Responsible Party

Thomas L Bradbury

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas L Bradbury, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Orthopedic and Spine Hospital

Tucker, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00066081

Identifier Type: -

Identifier Source: org_study_id