Clinical trial NCT05188053: Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty
Official title: Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A Single Institution, Single-blinded, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 \< 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.

Primary outcomes:
measure: Pain Control at 72 Hours Postoperatively
timeFrame: 72-hours postoperatively after total knee arthroplasty
Secondary outcomes:
measure: Pain Control at 48 Hours Postoperatively
timeFrame: 48-hours postoperative total knee arthroplasty
measure: Opioid Consumption 72 Hours Postoperatively
timeFrame: 72-hours postoperative total knee arthroplasty
measure: Opioid Consumption 48 Hours Postoperatively
timeFrame: 48 hours postoperative total knee arthroplasty
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew P Abdel, MD
role: PRINCIPAL_INVESTIGATOR
References: