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ZYNRELEF for Pain Management in Total Knee Arthroplasty
NCT05644496 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release
Study Locations (1)
Florida
- Doctors Hospital — Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2023-03-09 |
| Est. Completion | 2027-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05644496
The ClinicalTrials.gov registry entry for NCT05644496 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 242 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baptist Health South Florida, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 1 intervention — of which Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05644496 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05644496 about?
NCT05644496 is a clinical study titled "ZYNRELEF for Pain Management in Total Knee Arthroplasty". 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 a...
What is the current status of trial NCT05644496?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 242 participants. The study started on 2023-03-09. Estimated completion is 2027-12.
What conditions does trial NCT05644496 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Post Operative Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05644496?
The interventions under investigation include: Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05644496?
This trial is sponsored by Baptist Health South Florida, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05644496 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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