Inflammation, Osteoarthritis, Postoperative Pain
Conditions
Keywords
Osteoarthritis, Postoperative pain, Total knee arthroplasty, Orthopaedics, Inflammation
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.
Interventions
DRUGDexamethasone 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.
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.
DRUGStandard 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
DRUGPlacebo
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
Thomas L Bradbury
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively | Post-operative pain was 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 participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain. |
| Opioid Analgesic Usage | 1 day post-operatively | The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Day of Physical Therapy Clearance | Up to 3 days post-operatively | The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function. |
| Antiemetic Dose Administered | Post-operative Days 1 and 2 | Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed. |
| Blood Glucose | Baseline, Post-operative Day 1 | To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL). |
| 36-Item Short Form Health Survey (SF-36) Score | Baseline, 12 months post-operatively | The subjects' functional ability will be assessed using the SF-36 questionnaire. The SF-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. |
| Soft Tissue Swelling | 1 day post-operatively | Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. |
| Length of Hospital Stay | Up to 3 days post-operatively | The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery. |
| Number of Participants Readmitted to the Hospital | Up to 12 months post-operatively | The number of participants with hospital readmissions after being discharged were recorded. |
| Number of Participants With Wound Infections | Up to 12 months post-operatively | The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded. |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score | Baseline, 1, 4, and 12 months post-operatively | The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health. |
| Range of Motion (ROM) | Baseline, 1 day post-operatively, 1, 4, and 12 months 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone 20 mg The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Dexamethasone 20 mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Opioid Analgesic Usage
The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.
Time frame: 1 day post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone 20 mg | Opioid Analgesic Usage | 37.5 Oral Morphine Equivalents (OME) |
Primary
Pain Score
Post-operative pain was 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 participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.
Time frame: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexamethasone 20 mg | Pain Score | Baseline | 3 units on a scale |
| Dexamethasone 20 mg | Pain Score | End of hospital stay (up to 3 days post-operative) | 0 units on a scale |
| Dexamethasone 20 mg | Pain Score | 1 month post-operative | 0 units on a scale |
| Dexamethasone 20 mg | Pain Score | 4 months post-operative | 3 units on a scale |
| Dexamethasone 20 mg | Pain Score | 12 months post-operative | 0 units on a scale |
Secondary
36-Item Short Form Health Survey (SF-36) Score
The subjects' functional ability will be assessed using the SF-36 questionnaire. The SF-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.
Time frame: Baseline, 12 months post-operatively
Population: SF-36 scores are not available. The survey was either not administered or scores have been lost.
Secondary
Antiemetic Dose Administered
Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.
Time frame: Post-operative Days 1 and 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexamethasone 20 mg | Antiemetic Dose Administered | Post-operative Day 1 | 4 milligrams (mg) |
| Dexamethasone 20 mg | Antiemetic Dose Administered | Post-operative Day 2 | 0 milligrams (mg) |
Secondary
Blood Glucose
To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL).
Time frame: Baseline, Post-operative Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexamethasone 20 mg | Blood Glucose | Baseline | 100 mg/dL |
| Dexamethasone 20 mg | Blood Glucose | Post-operative Day 1 | 88 mg/dL |
Secondary
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score
The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health.
Time frame: Baseline, 1, 4, and 12 months post-operatively
Population: KOOS, JR. scores are not available. The survey was either not administered or scores have been lost.
Secondary
Length of Hospital Stay
The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.
Time frame: Up to 3 days post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone 20 mg | Length of Hospital Stay | 3 days |
Secondary
Number of Participants Readmitted to the Hospital
The number of participants with hospital readmissions after being discharged were recorded.
Time frame: Up to 12 months post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone 20 mg | Number of Participants Readmitted to the Hospital | 0 Participants |
Secondary
Number of Participants With Wound Infections
The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.
Time frame: Up to 12 months post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone 20 mg | Number of Participants With Wound Infections | 0 Participants |
Secondary
Post-operative Day of Physical Therapy Clearance
The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function.
Time frame: Up to 3 days post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone 20 mg | Post-operative Day of Physical Therapy Clearance | 3 days |
Secondary
Range of Motion (ROM)
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.
Time frame: Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexamethasone 20 mg | Range of Motion (ROM) | Baseline | 125 degrees |
| Dexamethasone 20 mg | Range of Motion (ROM) | 1 Day Post-Operative | 105 degrees |
| Dexamethasone 20 mg | Range of Motion (ROM) | 1 Month Post-Operative | 135 degrees |
| Dexamethasone 20 mg | Range of Motion (ROM) | 4 Months Post-Operative | 140 degrees |
| Dexamethasone 20 mg | Range of Motion (ROM) | 12 Months Post-Operative | 110 degrees |
Secondary
Soft Tissue Swelling
Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient.
Time frame: 1 day post-operatively
Population: Measurements of knee circumference were not obtained at any study time point, or measurements have been lost and are no longer available.