ZYNRELEF for Pain Management in Total Knee Arthroplasty

Baptist Health South Florida

Status and phase: Enrolling; Phase 4

Conditions: Osteoarthritis, Knee; Post Operative Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05644496

1891382

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients undergoing primary unilateral total knee arthroplasty [Current Procedural 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 knee arthroplasty procedure

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 cartilage debridement/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 drug components
    • History of asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDs

18. Patients taking the following medications:

    • Amitriptyline
    • Nortriptyline
    • Gabapentin
    • Pregabalin
    • Duloxetine (SNRI)
    • Des-Venlafaxine (SNRI)
    • Cyclobenzaprine
    • Baclofen

19. Pregnant or lactating females

20. Patients unable to provide informed consent

21. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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242 participants in 2 patient groups

Intervention

Experimental group

Description:

In addition to the standard-of-care arm description, single administration of Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release in the surgical site before complete wound closure.

Treatment:

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

Standard-of-care

No Intervention group

Description:

Usual standard of care procedure for knee replacement and pain management before, during and immediately following surgery.