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NCT05644496 · ClinicalTrials.gov registry record · Phase 4
ZYNRELEF for Pain Management in Total Knee Arthroplasty
A Phase 4 study of Postoperative Pain and Osteoarthritis, Knee, sponsored by Baptist Health South Florida.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 242
- Enrollment target
- 1
- Study location
NCT05644496: Recruiting Phase 4 study of Postoperative Pain and Osteoarthritis, Knee, sponsored by Baptist Health South Florida.
NCT05644496 is a Phase 4 study of Postoperative Pain and Osteoarthritis, Knee that is actively recruiting participants, run by Baptist Health South Florida. The registered enrollment target is 242 participants, roughly in line with the 230-participant average among 120 other Postoperative Pain trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05644496, a Phase 4 study of Postoperative Pain and Osteoarthritis, Knee, 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.
Primary Outcome
Amount of opioid analgesic consumed in the time frame calculated as Morphine Milligram Equivalent (MME).
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 |
What NCT05644496 shows while recruiting
NCT05644496 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 230-participant average among 120 other Postoperative Pain trials with a reported enrollment target.
The record links to 2 conditions, with Postoperative Pain 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 a single indexed study location in 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: Postoperative Pain, Osteoarthritis, Knee.
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.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05644496's enrollment target sits among peer trials
242 27th of 120 higher than 94 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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