Clinical trial NCT01582490: Study of EXPAREL in Patients Undergoing Breast Augmentation
Official title: Evaluation of the Safety and Efficacy of EXPAREL® (Bupivacaine Liposome Injectable Suspension) When Administered Via Infiltration Versus Instillation in Subjects Undergoing Bilateral Augmentation Mammoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mammoplasty
Postoperative Pain
Keywords: Mammoplasty
Postoperative pain
Analgesia
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Analgesia
timeFrame: 10 days
Secondary outcomes:
measure: Total Postsurgical Opioid Consumption in the Surgical Center
timeFrame: 10 days
measure: Pain Intensity Assessment Upon Waking in the PACU
timeFrame: Upon waking in the PACO post surgery
measure: Pain Intensity Assessment at the Time of Hospital Discharge
timeFrame: At the time of hospital discharge
measure: Time to Hospital Discharge Being Written
timeFrame: At the time of hospital discharge
measure: Incidence of Opioid-Related Adverse Events
timeFrame: Through 10 Days Post Surgery
measure: Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge
timeFrame: At the time of hospital discharge
measure: Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10
timeFrame: Day 10 after surgery
Other outcomes:
Locations:
city: Brighton
country: United States
facility: Steward St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Steward Research
name: Daniel Del Vecchio, MD
role: PRINCIPAL_INVESTIGATOR
References: