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Study of EXPAREL in Patients Undergoing Breast Augmentation

Primary Purpose

Mammoplasty, Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Instillation - EXPAREL
Infiltration - EXPAREL
Sponsored by
Pacira Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mammoplasty focused on measuring Mammoplasty, Postoperative pain, Analgesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Steward St. Elizabeth's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Infiltration - EXPAREL

Instillation - EXPAREL

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total Postsurgical Opioid Consumption in the Surgical Center
Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.
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.
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.
Time to Hospital Discharge Being Written
The time (hours) to the hospital discharge being written for subjects in each group,
Incidence of Opioid-Related Adverse Events
The incidence of adverse events that were assessed as opioid-related
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."
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."

Full Information

First Posted
April 19, 2012
Last Updated
May 31, 2014
Sponsor
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01582490
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacira Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mammoplasty, Postoperative Pain
Keywords
Mammoplasty, Postoperative pain, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infiltration - EXPAREL
Arm Type
Active Comparator
Arm 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.
Arm Title
Instillation - EXPAREL
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Instillation - EXPAREL
Other Intervention Name(s)
bupivacaine liposomal injectable suspension
Intervention Description
Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
Intervention Type
Drug
Intervention Name(s)
Infiltration - EXPAREL
Other Intervention Name(s)
bupivacaine liposomal injectable suspension
Intervention Description
IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
Primary Outcome Measure Information:
Title
Duration of Analgesia
Description
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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Total Postsurgical Opioid Consumption in the Surgical Center
Description
Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.
Time Frame
10 days
Title
Pain Intensity Assessment Upon Waking in the PACU
Description
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.
Time Frame
Upon waking in the PACO post surgery
Title
Pain Intensity Assessment at the Time of Hospital Discharge
Description
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.
Time Frame
At the time of hospital discharge
Title
Time to Hospital Discharge Being Written
Description
The time (hours) to the hospital discharge being written for subjects in each group,
Time Frame
At the time of hospital discharge
Title
Incidence of Opioid-Related Adverse Events
Description
The incidence of adverse events that were assessed as opioid-related
Time Frame
Through 10 Days Post Surgery
Title
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge
Description
Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."
Time Frame
At the time of hospital discharge
Title
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10
Description
Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."
Time Frame
Day 10 after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Del Vecchio, MD
Organizational Affiliation
Steward Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steward St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of EXPAREL in Patients Undergoing Breast Augmentation

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