NCT05188053

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

Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A Single Institution, Single-blinded, Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DRUG	HTX-011	Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution
DRUG	ropivacaine , epinephrine , ketorolac diluted in sodium chloride	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

Timeline

• Start date: 2022-03-11
• Primary completion: 2024-04-18
• Completion: 2024-04-18
• First posted: 2022-01-12
• Last updated: 2025-04-27
• Results posted: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study