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Fascial Plane Block for Cardiac Surgery and Opioid Use Disorder
Study Summary
This trial is testing a new pain relief method for heart surgery patients that could potentially decrease the amount of pain medication needed. 100 patients will be involved, and the trial will last 100 days.
- Cardiac Surgery
- Opioid Use Disorder
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- Group 1: PIFB intervention
- Group 2: Saline Control
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there any prior investigations that have explored the efficacy of Liposomal bupivacaine?
"Presently, 109 trials concerning liposomal bupivacaine are ongoing with 18 being at the critical Phase 3 stage. While Philadelphia is a major contributor to research in this field, there are 144 sites across North America running studies for it."
Are there any opportunities to become a participant in this experiment?
"Indeed, according to information on clinicaltrials.gov, this experiment is actively recruiting patients. As of October 4th 2022, the study has been open since March 28th 2020 and needs 100 individuals at a single site."
What is the regulatory status of Liposomal bupivacaine?
"Based on the Phase 4 status of Liposomal bupivacaine, our team at Power assessed its safety as a 3. This medication has already been approved for use in medical settings."
What is the scope of patient recruitment for this research endeavor?
"Yes, according to the clinicaltrials.gov database, this medical study is currently seeking participants. It was first posted on March 28th 2022 and updated most recently on October 4th of that same year. The trial necessitates 100 patients from one single site for successful completion."
What type of ailments can Liposomal bupivacaine be employed to alleviate?
"Liposomal bupivacaine is most commonly prescribed for permphigus, yet it has also proven effective in managing acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."
Is geriatric participation welcome in this investigation?
"This study is seeking participants that are within the age range of 18 and 80 years old."
What are the requirements for enrolment into this trial?
"Patients wishing to be included in this medical trial must have had surgery, a clean bill of cardiac health and fit within the age bracket 18-80. Approximately 100 participants are expected."
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