Study of EXPAREL in Patients Undergoing Breast Augmentation

Pacira

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Mammoplasty

Treatments: Drug: Infiltration - EXPAREL; Drug: Instillation - EXPAREL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01582490

MA402S23B901

Details and patient eligibility

About

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).

Full 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.

Enrollment: 19 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Infiltration - EXPAREL

Active Comparator group

Description:

Group 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.

Treatment:

Drug: Instillation - EXPAREL

Instillation - EXPAREL

Experimental group

Description:

Group 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.

Treatment:

Drug: Infiltration - EXPAREL