Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty
- Conditions
- Total Knee Arthroplasty
- Interventions
- Registration Number
- NCT05188053
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Block Control Group ropivacaine , epinephrine , ketorolac diluted in sodium chloride Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia HTX-011 Treatment Group HTX-011 Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia
- Primary Outcome Measures
Name Time Method Pain control at 72 hours 72-hours postoperative total knee arthroplasty Mean patient reported (0-10) numeric rating scale (NRS) pain scores at 72 hours postoperative
- Secondary Outcome Measures
Name Time Method Opioid consumption 72-hours postoperative total knee arthroplasty Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)
Hospital length of stay approximately 3 days Total number of days admitted to the hospital
Distance walked at time of discharge with PT approximately 3 days Distance walked by the participate with physical therapist (PT) at the time of discharge measured in meters
Pain control at 48 hours 48-hours postoperative total knee arthroplasty Mean patient reported (0-10) numeric rating scale (NRS) pain scores at 48 hours postoperative
Pain control at 24 hours 24-hours postoperative total knee arthroplasty Mean patient reported (0-10) numeric rating scale (NRS) pain scores at 24 hours postoperative
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States