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

• Status: Enrolling by invitation
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Epinephrine; Ketorolac; Ropivacaine

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 < 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.