Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-010044
NCT ID: NCT05188053
Sponsor Protocol Number: 21-010044
About this study
The purpose of this study is to investigate if bupivacaine +meloxicam ER solution is going to improve patient care at Mayo Clinic through superior and prolonged analgesia following total knee arthroplasty compared to our standard of care.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- ASA classification I to III, older than or equal to 18 years old.
- All genders.
- 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.
Eligibility last updated 10/12/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Matthew Abdel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available