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

Total Knee Arthroplasty Clinical Trial

Official title:

Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A Single Institution, Single-blinded, Randomized Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05188053
• Other study ID #: 21-010044
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: February 7, 2022
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 98
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Drug:
• HTX-011
Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain control at 72 hours	Mean patient reported (0-10) numeric rating scale (NRS) pain scores at 72 hours postoperative	72-hours postoperative total knee arthroplasty
Secondary	Pain control at 48 hours	Mean patient reported (0-10) numeric rating scale (NRS) pain scores at 48 hours postoperative	48-hours postoperative total knee arthroplasty
Secondary	Pain control at 24 hours	Mean patient reported (0-10) numeric rating scale (NRS) pain scores at 24 hours postoperative	24-hours postoperative total knee arthroplasty
Secondary	Opioid consumption	Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)	72-hours postoperative total knee arthroplasty
Secondary	Hospital length of stay	Total number of days admitted to the hospital	approximately 3 days
Secondary	Distance walked at time of discharge with PT	Distance walked by the participate with physical therapist (PT) at the time of discharge measured in meters	approximately 3 days

External Links

•   Mayo Clinic Clinical Trials