At a glance
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Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A Single Institution, Single-blinded, Randomized Clinical Trial
In Brief
A Phase 4 clinical trial evaluating HTX-011 and ropivacaine , epinephrine , ketorolac diluted in sodium chloride for Total Knee Arthroplasty. Completed, enrolled 209 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
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