ZYNRELEF for Pain Management in Total Knee Arthroplasty

Last updated: April 16, 2025
Sponsor: Baptist Health South Florida
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release

Clinical Study ID

NCT05644496
1891382
  • Ages 35-70
  • All Genders

Study Summary

The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement.

The main questions it aims to answer are:

  • How well does the study drug control pain in the days after surgery?

  • Does the study drug reduce the amount of opioid analgesic consumed after surgery?

Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam).

Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients undergoing primary unilateral total knee arthroplasty [CurrentProcedural Terminology Code: 27447]

  2. Patients with a diagnosis of primary osteoarthritis [ICD-10 codes: M17.0, M17.10,M17.11, M17.12]

  3. Varus deformity less than 10 degrees

  4. Flexion contracture less than 10 degrees

  5. Age 35 - 70 years old

  6. BMI < 40

  7. Patients who are discharged on the same day after the unilateral total kneearthroplasty procedure

Exclusion

Exclusion Criteria:

  1. Inflammatory arthritis

  2. Post-traumatic arthritis

  3. Valgus deformity

  4. Severe varus (> 10 degrees)

  5. Severe flexion contracture (> 10 degrees)

  6. Overnight or longer hospital stay after surgery

  7. Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilagedebridement/repair

  8. Creatinine > 1.2

  9. Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease

  10. Uncontrolled Diabetes mellitus (Glycated Hemoglobin > 8.0%)

  11. Current liver disease

  12. Personal history of depression or anxiety disorder

  13. Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE)

  14. Narcotic or tramadol use within 2 weeks of the planned procedure

  15. Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics

  16. Walking aid for anything other than the operative joint

  17. Contraindication for use of the study drug (as specified by the manufacturer):

  • Known hypersensitivity to local amide anesthetics, NSAIDs or study drugcomponents

  • History of asthma, urticaria or other allergic-type reactions to aspirin orother NSAIDs

  1. Patients taking the following medications:

  • Amitriptyline

  • Nortriptyline

  • Gabapentin

  • Pregabalin

  • Duloxetine (SNRI)

  • Des-Venlafaxine (SNRI)

  • Cyclobenzaprine

  • Baclofen

  1. Pregnant or lactating females

  2. Patients unable to provide informed consent

  3. Subjects who, in the opinion of the Investigator, may be non-compliant with studyschedules or procedures

Study Design

Total Participants: 242
Treatment Group(s): 1
Primary Treatment: Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release
Phase: 4
Study Start date:
March 09, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Doctors Hospital

    Miami, Florida 33146
    United States

    Active - Recruiting

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