The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
209
Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution
Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Pain Control at 72 Hours Postoperatively
Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-72 hours) / NRS AUC 0-72. Pain scores were collected by patient self-report 15 times over the 72 hours after surgery, and averaged amongst the patients for each study arm. Lower values represent better pain control based on lower mean 0-10 pain scores over the 72 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 15 time points within 72 hours. The maximum value would be 720, meaning patients reported a 10 for pain on a 0-10 scale at all 15 time points within 72 hours.
Time frame: 72-hours postoperatively after total knee arthroplasty
Pain Control at 48 Hours Postoperatively
Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-48 hours) / NRS AUC 0-48. Pain scores were collected by patient self-report 11 times over the 48 hours after surgery, and averaged amongst the patients for each study arm. Lower values represent better pain control based on lower mean 0-10 pain scores over the 48 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 11 time points within 48 hours. The maximum value would be 480, meaning patients reported a 10 for pain on a 0-10 scale at all 11 time points within 48 hours
Time frame: 48-hours postoperative total knee arthroplasty
Opioid Consumption 72 Hours Postoperatively
Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)
Time frame: 72-hours postoperative total knee arthroplasty
Opioid Consumption 48 Hours Postoperatively
Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)
Time frame: 48 hours postoperative total knee arthroplasty
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