drugset / Trial / NCT05188053

Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty

NCT05188053

Phase 4 Completed 209 enrolled Mayo Clinic
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-03-11
Primary completion
2024-04-18
Completion
2024-04-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Epinephrine Other / unclassified 0.6 mg
Subject HTX-011 Unknown 12 mg Other
Subject HTX-011 Unknown 400 mg Other
Comparator Ketorolac Other / unclassified 30 mg
Comparator Ropivacaine Other / unclassified 225 mg

Indications

No indication recorded.