Study of EXPAREL in Patients Undergoing Breast Augmentation

Phase 4

Completed

Conditions: Postoperative Pain
Mammoplasty

Interventions: Drug: Instillation - EXPAREL
Drug: Infiltration - EXPAREL

Registration Number: NCT01582490

Lead Sponsor: Pacira Pharmaceuticals, Inc

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 19

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infiltration - EXPAREL	Instillation - EXPAREL	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.
Instillation - EXPAREL	Infiltration - EXPAREL	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.

Primary Outcome Measures

Name	Time	Method
Duration of Analgesia	10 days	The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity Assessment Upon Waking in the PACU	Upon waking in the PACO post surgery	Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain.
Pain Intensity Assessment at the Time of Hospital Discharge	At the time of hospital discharge	Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain.
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10	Day 10 after surgery	Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."
Total Postsurgical Opioid Consumption in the Surgical Center	10 days	Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.
Time to Hospital Discharge Being Written	At the time of hospital discharge	The time (hours) to the hospital discharge being written for subjects in each group,
Incidence of Opioid-Related Adverse Events	Through 10 Days Post Surgery	The incidence of adverse events that were assessed as opioid-related
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge	At the time of hospital discharge	Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."