Study of EXPAREL in Patients Undergoing Breast Augmentation

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582490
• Other study ID #: MA402S23B901
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2012
• Last updated: May 31, 2014
• Start date: April 2012
• Est. completion date: November 2012

Study information

• Verified date: May 2014
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mammoplasty
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Instillation - EXPAREL
Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
• Infiltration - EXPAREL
IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Locations

Country	Name	City	State
United States	Steward St. Elizabeth's Medical Center	Brighton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Analgesia	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.	10 days	No
Secondary	Total Postsurgical Opioid Consumption in the Surgical Center	Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.	10 days	No
Secondary	Pain Intensity Assessment Upon Waking in the PACU	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.	Upon waking in the PACO post surgery	Yes
Secondary	Pain Intensity Assessment 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.	At the time of hospital discharge	Yes
Secondary	Time to Hospital Discharge Being Written	The time (hours) to the hospital discharge being written for subjects in each group,	At the time of hospital discharge	Yes
Secondary	Incidence of Opioid-Related Adverse Events	The incidence of adverse events that were assessed as opioid-related	Through 10 Days Post Surgery	Yes
Secondary	Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge	Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."	At the time of hospital discharge	Yes
Secondary	Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10	Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."	Day 10 after surgery	Yes