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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 24 hours for 120 hours following surgical procedure
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pain assessment scores
Total opioid analgesic consumption
Secondary outcome measures
Incidence of major complications
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.
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Who is running the clinical trial?
Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,589 Total Patients Enrolled
Juan C Suarez, MDPrincipal InvestigatorBaptist Health South Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to local anesthetics, NSAIDs, or any components of the study drug.My blood sugar levels are not well-controlled (HbA1c > 8.0%).I have not used narcotics or tramadol in the last 2 weeks.I use a walking aid for reasons not related to my surgery site.I have been diagnosed with primary osteoarthritis.I have a liver condition.I have a history of depression or anxiety.I am allergic to aspirin, NSAIDs, oxycodone, Tylenol, or local anesthetics.I am able to understand and agree to the study's procedures and risks.I have inflammatory arthritis.My kidney function is significantly reduced.Your creatinine level is higher than 1.2.I have arthritis caused by a previous injury.I stayed in the hospital overnight or longer after my surgery.I went home the same day after my knee replacement surgery.Your leg is not bent inward by more than 10 degrees.You are not extremely overweight.I have had a deep vein clot or a lung clot in the past.I am an adult scheduled for a first-time knee replacement on one knee.My knee bends significantly inward.I am currently taking medication for nerve pain or depression.My joint stiffness limits bending by less than 10 degrees.I am between 35 and 70 years old.You have a condition where your joint bends outward.I have had surgery on my knee, but only for meniscal or cartilage issues.You have had asthma, hives, or other allergic reactions to aspirin or other similar medicines.I cannot fully straighten my joint due to severe stiffness.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Standard-of-care
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical study open to individuals over the age of 55?
"The consent form for this medical study dictates that participants must be over the age of 35 and beneath 70 years old."
Answered by AI
Are there any openings left in this investigation for potential participants?
"Data on clinicaltrials.gov indicates that, while this particular study is no longer recruiting patients (the last edit was made December 7th 2022), there are still 926 other trials actively seeking participants at the present time."
Answered by AI
What risks do participants in this intervention face?
"There is a wealth of evidence to suggest the safety of this intervention, thereby warranting it's score of 3. This treatment has been approved as part of Phase 4 clinical trials."
Answered by AI
Am I eligible to participate in this investigation?
"The requirements to join this medical trial are that patients have osteoarthritis of the knee, and be between 35-70 years old. The team is looking for 242 participants in total."
Answered by AI
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