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ZYNRELEF for Postoperative Knee Pain

Phase 4

Recruiting

Led By Juan C Suarez, MD

Research Sponsored by Baptist Health South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a diagnosis of primary osteoarthritis [ICD-10 codes: M17.0, M17.10, M17.11, M17.12]

Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure

Must not have

Contraindication for use of the study drug (as specified by the manufacturer): Known hypersensitivity to local amide anesthetics, NSAIDs or study drug components

Uncontrolled Diabetes mellitus (Glycated Hemoglobin > 8.0%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and every 24 hours for 120 hours following surgical procedure

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing opioid usage after knee surgery for those given a new medication vs. those given usual care.

Who is the study for?

This trial is for adults aged 35-70 with primary osteoarthritis planning a total knee replacement. Eligible participants must have a BMI under 40, be discharged the same day as surgery, and have certain limits on knee deformity. Exclusions include inflammatory arthritis, kidney disease, uncontrolled diabetes, liver disease, mental health disorders, allergies to specific drugs including NSAIDs and local anesthetics, prior significant knee surgeries or conditions that affect walking.

What is being tested?

The study tests Zynrelef (a bupivacaine-meloxicam injectable solution) for pain management after total knee replacement surgery. It aims to see if Zynrelef can control pain better and reduce opioid use compared to standard care in the days following surgery. Participants are randomly assigned to receive either Zynrelef or usual postoperative care.

What are the potential side effects?

Potential side effects of Zynrelef may include reactions at the injection site such as redness or swelling, nausea or vomiting due to anesthesia-related effects; headache; itching; fever; back pain; constipation from opioids taken for breakthrough pain; dizziness and sleep disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with primary osteoarthritis.

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I went home the same day after my knee replacement surgery.

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I am an adult scheduled for a first-time knee replacement on one knee.

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My joint stiffness limits bending by less than 10 degrees.

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I am between 35 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to local anesthetics, NSAIDs, or any components of the study drug.

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My blood sugar levels are not well-controlled (HbA1c > 8.0%).

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I use a walking aid for reasons not related to my surgery site.

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I have a liver condition.

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I have a history of depression or anxiety.

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I am allergic to aspirin, NSAIDs, oxycodone, Tylenol, or local anesthetics.

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I am able to understand and agree to the study's procedures and risks.

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I have inflammatory arthritis.

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My kidney function is significantly reduced.

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I have arthritis caused by a previous injury.

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I stayed in the hospital overnight or longer after my surgery.

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I have had a deep vein clot or a lung clot in the past.

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My knee bends significantly inward.

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I am currently taking medication for nerve pain or depression.

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I have had surgery on my knee, but only for meniscal or cartilage issues.

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I cannot fully straighten my joint due to severe stiffness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and every 24 hours for 120 hours following surgical procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and every 24 hours for 120 hours following surgical procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 24 hours for 120 hours following surgical procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain assessment scores

Total opioid analgesic consumption

Secondary study objectives

Incidence of major complications

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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 II: Standard-of-careActive Control1 Intervention

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

0 / 21Eligibility criteria met