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Completed

NCT Number: NCT05188053

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

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HTX-011

Drug

Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution

Other names: Zynrelef

ropivacaine , epinephrine , ketorolac diluted in sodium chloride

Drug

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: Mayo Clinic standard arthroplasty block

Primary outcomes

  1. Pain Control at 72 Hours Postoperatively

    Time frame: 72-hours postoperatively after total knee arthroplasty

    Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-72 hours) / NRS AUC 0-72. Pain scores were collected by patient self-report 15 times over the 72 hours after surgery, and averaged amongst the patients for each study arm.

    Lower values represent better pain control based on lower mean 0-10 pain scores over the 72 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 15 time points within 72 hours. The maximum value would be 720, meaning patients reported a 10 for pain on a 0-10 scale at all 15 time points within 72 hours.

Secondary outcomes

  1. Pain Control at 48 Hours Postoperatively

    Time frame: 48-hours postoperative total knee arthroplasty

    Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-48 hours) / NRS AUC 0-48. Pain scores were collected by patient self-report 11 times over the 48 hours after surgery, and averaged amongst the patients for each study arm.

    Lower values represent better pain control based on lower mean 0-10 pain scores over the 48 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 11 time points within 48 hours. The maximum value would be 480, meaning patients reported a 10 for pain on a 0-10 scale at all 11 time points within 48 hours

  2. Opioid Consumption 72 Hours Postoperatively

    Time frame: 72-hours postoperative total knee arthroplasty

    Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)

  3. Opioid Consumption 48 Hours Postoperatively

    Time frame: 48 hours postoperative total knee arthroplasty

    Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2022
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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