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 range18 Years – 75 Years
SexFEMALE
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.