Total Knee Arthroplasty
Conditions
Keywords
dexamethasone, opioid consumption, postoperative pain
Brief summary
The purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.
Detailed description
Study design: Prospective randomized controlled trial Scientific Background: In contemporary total joint arthroplasty (TJA), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 Multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. Corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols. Corticosteroids are frequently used in TJA due to their potent anti-inflammatory and anti-emetic properties. Several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 However, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. In addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. Thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during TJA.
Interventions
DRUGDexamethasone 4mg
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
DRUGDexamethasone 8 Mg/mL Injectable Suspension
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 years * Primary total knee arthroplasty * Patients staying at least one night in the hospital after surgery
Exclusion criteria
* Same day discharge Age \< 18 years Revision or partial total knee arthroplasty Corticosteroid use within 3 months prior to surgery Inflammatory arthritis Current systemic fungal infection Renal or liver failure Prior adverse reaction to corticosteroid Primary TKA requiring hardware removal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 48-hours postoperative (after surgical intervention) | 48 hours of cumulative opioid consumption measured in oral morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores at Rest | assessed at days 1 through 7 after surgery, Day 7 reported | Using daily Defense and Veterans Pain Rating scale (VPRS) to rate pain at rest, on a scale of 0-10 where 0 means no pain and 10 is the highest pain |
| Postoperative Nausea | assessed at days 1 through 7 after surgery, Day 7 reported | Using numeric rating scale, (0-10, where 10 is most nausea). |
| Postoperative Blood Glucose Levels Without Diabetes | Glucose levels taken the morning after surgery | check glucose levels in blood draws the morning after surgery in mg/dL |
| Postoperative Blood Glucose Levels With Diabetes | Glucose levels taken the morning after surgery | check glucose levels, blood draws on morning after surgery measured in mg/dL |
| Number of Hours Slept Post Op Day 1 | Post op day 1, recording of hours slept | recorded by patient, reported number of hours slept each night for first week after surgery |
| Number of Hours Slept Post Op Day 2 | Post op day 2, hours slept | recorded by patient, reported number of hours slept each night for first week after surgery |
| Number of Hours Slept Post Op Day 3 | Post op day 3, hours slept | recorded by patient, reported number of hours slept each night for first week after surgery |
| Number of Hours Slept Post Op Day 4 | Hours slept on POD 4 | recorded by patient, reported number of hours slept each night for first week after surgery |
| Number of Hours Slept Post Op Day 5 | Hours slept on POD 5 | recorded by patient, reported number of hours slept each night for first week after surgery |
| Number of Hours Slept Post Op Day 6 | Hours slept on POD 6 | recorded by patient, reported number of hours slept each night for first week after surgery |
| Number of Hours Slept Post Op Day 7 | Hours slept on POD 7 | recorded by patient, reported number of hours slept each night for first week after surgery |
| Number of Participants With Complications up to 30 Days After Surgical Intervention | <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery | Complications and Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 8.9 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 138 | 0 / 137 | 0 / 129 |
| other Total, other adverse events | 3 / 138 | 1 / 137 | 3 / 129 |
| serious Total, serious adverse events | 2 / 138 | 1 / 137 | 3 / 129 |
Outcome results
None listed