Clinical trial NCT05644496: ZYNRELEF for Pain Management in Total Knee Arthroplasty
Official title: A Randomized Controlled Trial of ZYNRELEF Versus Standard of Care for Pain Management Following Unilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post Operative Pain
Osteoarthritis, Knee
Keywords: Knee Arthroplasty
Postoperative pain management
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 242
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total opioid analgesic consumption
timeFrame: 5 days following surgical procedure
measure: Change in pain assessment scores
timeFrame: Baseline and every 24 hours for 120 hours following surgical procedure
Secondary outcomes:
measure: Incidence of major complications
timeFrame: 42 days following surgical procedure
Other outcomes:
Locations:
city: Miami
country: United States
facility: Doctors Hospital
state: Florida
Study officials:
affiliation: Baptist Health South Florida
name: Juan C Suarez, MD
role: PRINCIPAL_INVESTIGATOR
References: