Study of EXPAREL in Patients Undergoing Breast Augmentation (NCT01582490) | Clinical Trial Compass
CompletedPhase 4
Study of EXPAREL in Patients Undergoing Breast Augmentation
United States19 participantsStarted 2012-04
Plain-language summary
This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female, 18-75 years of age inclusive.
* American Society of Anesthesiologists (ASA) physical status 1-3.
* Undergoing bilateral augmentation mammoplasty without any concurrent surgical procedure(s).
* Physically and mentally able to participate in the study and complete all study assessments.
* Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the study components.
Exclusion Criteria:
* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
* Any subject whose anatomy or surgical procedure might, in the opinion of the Investigator, preclude the potential successful local administration of EXPAREL.
* Subjects currently pregnant or who may become pregnant during the course of the study.
* Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
* Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.