ZYNRELEF for Pain Management in Total Knee Arthroplasty

NCT ID: NCT05644496

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Post Operative Pain; Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Instillation of the drug into the knee joint capsule and surrounding tissues after placing the knee prosthesis and before close of the surgical wound

Standard-of-care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Instillation of the drug into the knee joint capsule and surrounding tissues after placing the knee prosthesis and before close of the surgical wound

Intervention Type: DRUG

Other Intervention Names

Zynrelef

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baptist Health South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan C Suarez, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Health South Florida

Locations

Doctors Hospital

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yvette Hernandez

Role: CONTACT

yvettesal@baptisthealth.net

786-308-2217

Chukwuemeka Osondu

Role: CONTACT

emekao@baptisthealth.net

786-308-2011

Facility Contacts

Yvette Hernandez

Role: primary

yvettesal@baptisthealth.net

Chukwuemeka Osondu, MD

Role: backup

emekao@baptisthealth.net

Other Identifiers

1891382

Identifier Type: -

Identifier Source: org_study_id