drugset / Trial / NCT05188053
Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty
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
Outcome
Missed primary endpoint
registry analysis (other test); HTX-011 Treatment Group vs Standard Block Control Group; p = 0.170; t-test, 2 sided; NCT05188053 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.