ZYNRELEF for Pain Management in Total Knee Arthroplasty

NCT05644496 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1891382
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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

Keywords

Knee Arthroplasty; Postoperative pain management

Outcome Measures

Primary Outcomes (2)

• Total opioid analgesic consumption

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

  5 days following surgical procedure

• Change in pain assessment scores

  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.

  Baseline and every 24 hours for 120 hours following surgical procedure

Secondary Outcomes (1)

• Incidence of major complications

  42 days following surgical procedure

Study Arms (2)

Intervention

EXPERIMENTAL

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

Standard-of-care

NO INTERVENTION

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

Interventions

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

Also known as: Zynrelef

Intervention

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing primary unilateral total knee arthroplasty \[Current Procedural Terminology Code: 27447\]
• Patients with a diagnosis of primary osteoarthritis \[ICD-10 codes: M17.0, M17.10, M17.11, M17.12\]
• Varus deformity less than 10 degrees
• Flexion contracture less than 10 degrees
• Age 35 - 70 years old
• BMI \< 40
• Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure

You may not qualify if:

• Inflammatory arthritis
• Post-traumatic arthritis
• Valgus deformity
• Severe varus (\> 10 degrees)
• Severe flexion contracture (\> 10 degrees)
• Overnight or longer hospital stay after surgery
• Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repair
• Creatinine \> 1.2
• Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease
• Uncontrolled Diabetes mellitus (Glycated Hemoglobin \> 8.0%)
• Current liver disease
• Personal history of depression or anxiety disorder
• Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE)
• Narcotic or tramadol use within 2 weeks of the planned procedure
• Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics

Sponsors & Collaborators

• Baptist Health South Florida: lead

Study Sites (1)

Doctors Hospital

Miami, Florida, 33146, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Interventions

bupivacaine-meloxicam drug combination

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Juan C Suarez, MD

  Baptist Health South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvette Hernandez

CONTACT

786-308-2217; yvettesal@baptisthealth.net

Chukwuemeka Osondu

CONTACT

786-308-2011; emekao@baptisthealth.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 9, 2022
• Study Start: March 9, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)