Status:
COMPLETED
Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty
Lead Sponsor:
Mayo Clinic
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 to...
Eligibility Criteria
Inclusion
- 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
- Vulnerable study populations including prisoners.
- Patients with a contralateral total knee arthroplasty \< 2 years prior to the index procedure.
- Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative.
- Patients unable to provide their own informed consent.
- Pregnancy.
- Patients with documented chronic pain syndromes.
- Patients with a history of prolonged daily opioids (more than 1 month) with an oral morphine equivalent of greater than 5mg/day.
- BMI \> 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.
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2024
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT05188053
Start Date
March 11 2022
End Date
April 18 2024
Last Update
April 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905