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Steroids in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219581
Recruitment Status : Suspended (Suspended pending acquisition of additional study staff.)
First Posted : August 19, 2014
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas L Bradbury, MD, Emory University

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Inflammation Osteoarthritis Drug: Dexamethasone 10 mg Drug: Dexamethasone 20 mg Drug: Standard multimodal pain management regimen Drug: Placebo Phase 4

Detailed Description:
Adequate pain control after total knee replacement (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty
Study Start Date : August 2014
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Placebo Comparator: 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.
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. (15 mg if older patient or CrCl 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 PCA: only for failure of the above
  • 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.

Experimental: 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.
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.
Other Name: Decadron

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. (15 mg if older patient or CrCl 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 PCA: only for failure of the above
  • MS Contin: Use as backup prn pain

Experimental: 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.
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.
Other Name: Decadron

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. (15 mg if older patient or CrCl 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 PCA: only for failure of the above
  • MS Contin: Use as backup prn pain




Primary Outcome Measures :
  1. Change in pain scores [ Time Frame: Baseline, 48 hours post-operatively (average length of inpatient stay) ]
    Postoperative pain will be assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= "No hurt", to a crying face at 10= "Hurts worst". The subject will be asked to choose the face that best describes their level of pain and their responses will be recorded. Higher scores indicate higher intensities of pain.

  2. Pain scores as recorded by the smart device app [ Time Frame: 7 days post-operatively ]
    Subjects will answer questions about their pain and record their responses using the app on their smart device.

  3. Change in pain scores [ Time Frame: 1 month post-operatively, 12 months post-operatively ]
    Postoperative pain will be assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= "No hurt", to a crying face at 10= "Hurts worst". The subject will be asked to choose the face that best describes their level of pain and their responses will be recorded. Higher scores indicate higher intensities of pain.

  4. Opioid analgesic usage [ Time Frame: Baseline, 2 weeks post-operatively ]
    The amount of each subject's postoperative opioid analgesic usage (converted into milligrams of morphine equivalents per day) will be recorded. The subjects will be asked to use a pain medication usage log to track the use of both prescribed narcotic medications and over the counter non-steroidal anti-inflammatory medications for knee pain.


Secondary Outcome Measures :
  1. Soft tissue swelling [ Time Frame: Baseline, 1 day post-operatively ]
    Soft tissue swelling will be evaluated using a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. This measurement will be completed twice, and the average of the two measurements will be used as the value for that day.

  2. Soft tissue swelling [ Time Frame: 1 month post-operatively, 12 months post-operatively ]
    Soft tissue swelling will be evaluated using a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. This measurement will be completed twice, and the average of the two measurements will be the value for that day.

  3. Change in range of motion (ROM) [ Time Frame: Baseline, 1 day post-operatively ]
    Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.

  4. Change in range of motion (ROM) [ Time Frame: 1 month post-operaively, 12 months post-opreatively ]
    Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.

  5. Time to clearance from physical therapy [ Time Frame: 2 days post-operatively ]
    The post-operative day when the subject is cleared by the physical therapy staff to go home will be recorded. A shorter clearance time is indicative of better joint function.

  6. Post-operative nausea [ Time Frame: Up to 1 month post-operatively ]
    The use of as-needed antiemetics will be recorded for each subject. Subjects will also be specifically asked about episodes of emesis using the BARF scale where each item is scored from 0= no nausea to 10= emesis.

  7. Post-operative vomiting [ Time Frame: Up to 1 month post-operatively ]
    The use of as-needed antiemetics will be recorded for each subject. Subjects will also be specifically asked about episodes of emesis using the BARF scale where each item is scored from 0= no nausea to 10= emesis.

  8. Levels of blood glucose [ Time Frame: Baseline, 48 hours post-operatively ]
    The subject's blood glucose level will be analyzed using a Hemocue analyzer.

  9. Functionality scores using Short Form using (SF)-36 [ Time Frame: Baseline, 12 months post-operatively ]
    The subjects' functional ability will be assessed using the Short Form (SF)-36 questionnaire. The Short Form-36 Health Survey is a 36-item, self-reported survey of patient health and is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability.

  10. Functionality scores using (WOMAC) [ Time Frame: Baseline, 12 months post-operatively ]
    The and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire will be used to assess joint function. administered to patients at the baseline visit and at each follow up clinic visit. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  11. Length of hospital stay [ Time Frame: 12 months post-operatively ]
    The length of each subject's hospital stay in days will be recorded. Higher number of days in the hospital indicate slower recovery.

  12. Number of hospital readmissions [ Time Frame: 12 months post-operatively ]
    The number of subjects who need readmission to the hospital will be recorded.

  13. Number of subjects with wound infections [ Time Frame: 1 month post-operatively, 12 months post-operatively ]
    The number of subjects with the clinical presence of wound drainage and periprosthetic infection will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219581


Locations
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United States, Georgia
Emory Orthopedic and Spine Hospital
Tucker, Georgia, United States, 30084
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Thomas L Bradbury, MD Emory University
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Responsible Party: Thomas L Bradbury, MD, Thomas L Bradbury MD, Emory University
ClinicalTrials.gov Identifier: NCT02219581    
Other Study ID Numbers: IRB00066081
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Keywords provided by Thomas L Bradbury, MD, Emory University:
Osteoarthritis
Postoperative pain
Total knee arthroplasty
Orthopaedics
Inflammation
Additional relevant MeSH terms:
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Osteoarthritis
Inflammation
Pain, Postoperative
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action