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NCT05644496 · ClinicalTrials.gov registry record · Phase 4
ZYNRELEF for Pain Management in Total Knee Arthroplasty
A Phase 4 study of Osteoarthritis, Knee and Post Operative Pain, sponsored by Baptist Health South Florida.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 242
- Enrollment target
- 1
- Study location
NCT05644496 is a Phase 4 study of Osteoarthritis, Knee and Post Operative Pain that is actively recruiting participants, run by Baptist Health South Florida. The registered enrollment target is 242 participants, below the 577-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05644496, a Phase 4 study of Osteoarthritis, Knee and Post Operative Pain, is actively recruiting participants, sponsored by Baptist Health South Florida.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 242 participants
- Enrollment target
- 1
- Study location
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, categorized as Phase 4. The registered enrollment target is 242 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 577-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (58% lower). The listed sponsor is Baptist Health South Florida, which has 40 total studies on file at ClinicalTrials.gov.
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.
NCT05644496 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
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.
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).
Who is sponsoring clinical trial NCT05644496?
This trial is sponsored by Baptist Health South Florida, which has 40 total clinical trials registered on ClinicalTrials.gov.
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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Related
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