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

Mayo Clinic

Status and phase

Completed

Phase 4

Conditions

Total Knee Arthroplasty

Treatments

Drug: ropivacaine , epinephrine , ketorolac diluted in sodium chloride

Drug: HTX-011

Study type

Interventional

Funder types

Other

Identifiers

NCT05188053

21-010044

Details and patient eligibility

About

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.

Enrollment

209 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.