Completed
Evaluation of the Safety and Efficacy of EXPAREL® (Bupivacaine Liposome Injectable Suspension) When Administered Via Infiltration Versus Instillation in Subjects Undergoing Bilateral Augmentation Mammoplasty
What is being tested
Instillation - EXPAREL
+ Infiltration - EXPAREL
Drug
Who is being recruted
Agnosia+8
+ Nervous System Diseases
+ Neurologic Manifestations
From 18 to 75 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: April 2012
Summary
Principal SponsorPacira Pharmaceuticals, Inc
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2012
Actual date on which the first participant was enrolled.Each subject underwent bilateral augmentation mammoplasty and received the same dose of EXPAREL. This primary objective of this study was to assess the efficacy of EXPAREL when administered via infiltration versus instillation as part of bilateral augmentation mammoplasty. The secondary objectives were to further assess other efficacy measures and the safety profile of EXPAREL.
Official TitleEvaluation of the Safety and Efficacy of EXPAREL® (Bupivacaine Liposome Injectable Suspension) When Administered Via Infiltration Versus Instillation in Subjects Undergoing Bilateral Augmentation Mammoplasty
Principal SponsorPacira Pharmaceuticals, Inc
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
19 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AgnosiaNervous System DiseasesNeurologic ManifestationsPainPain, PostoperativePathologic ProcessesPerceptual DisordersPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations
Criteria
5 inclusion criteria required to participate
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.
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5 exclusion criteria prevent from participating
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.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery.
Group II
ExperimentalGroup 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Steward St. Elizabeth's Medical Center
Brighton, United StatesOpen Steward St. Elizabeth's Medical Center in Google MapsCompletedOne Study Center