Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HTX-011 Treatment Group Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia |
Drug: HTX-011
Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution
Other Names:
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| Active Comparator: Standard Block Control Group Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia |
Drug: ropivacaine , epinephrine , ketorolac diluted in sodium chloride
Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASA classification I to III, older than or equal to 18 years old.
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Presenting for primary total knee replacement for degenerative joint disease.
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Patient capable of providing their own informed consent.
Exclusion Criteria:
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Vulnerable study populations including prisoners.
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Patients with a contralateral total knee arthroplasty < 2 years prior to the index procedure.
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Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative.
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Patients unable to provide their own informed consent.
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Pregnancy.
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Patients with documented chronic pain syndromes.
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Patients with a history of prolonged daily opioids (more than 1 month) with an oral morphine equivalent of greater than 5mg/day.
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BMI > 45 kg/m^2.
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Allergies to any component of the study medications, including specific history of type 1 hypersensitivities to any NSAID.
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Patients with impaired cognitive function.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Matthew P Abdel, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-010044