Phase 4
N=190
Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty
Total Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT05188053 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Pain Control at 72 Hours Postoperatively — 334; 370 score on a scale * hours — p=0.170
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HTX-011 (Drug); ropivacaine , epinephrine , ketorolac diluted in sodium chloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Control at 72 Hours Postoperatively |
334; 370 | 0.170 |
| SECONDARY Pain Control at 48 Hours Postoperatively |
237; 268 | — |
| SECONDARY Opioid Consumption 72 Hours Postoperatively |
85; 77 | — |
| SECONDARY Opioid Consumption 48 Hours Postoperatively |
67; 60 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ASA classification I to III, older than or equal to 18 years old.
- Presenting for primary total knee replacement for degenerative joint disease.
- Patient capable of providing their own informed consent.
Exclusion Criteria
- Vulnerable study populations including prisoners.
- Patients with a contralateral total knee arthroplasty 45 kg/m^2.
- Allergies to any component of the study medications, including specific history of type 1 hypersensitivities to any NSAID.
- Patients with impaired cognitive function.
- Major systemic illnesses such as severe renal (estimated glomerular filtration rate less than 50ml/min), coronary artery disease requiring a bypass graft (CABG), other cardiac problems including congestive heart failure (CHF New York Heart Association class III to IV), or severe hepatic disorders defined as current or past diagnosis of acute/subacute liver necrosis, acute hepatic failure, chronic liver disease, liver abscess, hepatic coma, hepatorenal syndrome and other disorders of the liver.
Data sourced from ClinicalTrials.gov (NCT05188053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.