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ZYNRELEF for Pain Management in Total Knee Arthroplasty

Sponsor
Baptist Health South Florida (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05644496
Collaborator
(none)
242
Enrollment
1
Location
2
Arms
39
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of ZYNRELEF Versus Standard of Care for Pain Management Following Unilateral Total Knee Arthroplasty
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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
Other Names:
  • Zynrelef

    		•
    No Intervention: Standard-of-care

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

    Outcome Measures

    Primary Outcome Measures

    1. Total opioid analgesic consumption [5 days following surgical procedure]

      Amount of opioid analgesic consumed in the time frame calculated as Morphine Milligram Equivalent (MME).

    2. Change in pain assessment scores [Baseline and every 24 hours for 120 hours following surgical procedure]

      Pain assessment scores using the pain Numeric Rating Scale for pain (NRS). The NRS scale is measured on a scale of 0 - 10, where 0 is no pain and 10 is the most severe pain.

    Secondary Outcome Measures

    1. Incidence of major complications [42 days following surgical procedure]

      Number of procedure-related adverse events and medication-related adverse events.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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 study schedules or procedures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Doctors Hospital Miami Florida United States 33146

    Sponsors and Collaborators

    • Baptist Health South Florida

    Investigators

    • Principal Investigator: Juan C Suarez, MD, Baptist Health South Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baptist Health South Florida
    ClinicalTrials.gov Identifier:
    NCT05644496
    Other Study ID Numbers:
    • 1891382
    First Posted:
    Dec 9, 2022
    Last Update Posted:
    Dec 9, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Baptist Health South Florida
    Knee Arthroplasty
    Postoperative pain management
    Additional relevant MeSH terms:
    Osteoarthritis, Knee
    Pain, Postoperative
    Meloxicam
    Bupivacaine

    Study Results

    No Results Posted as of Dec 9, 2022