Study of EXPAREL in Patients Undergoing Breast Augmentation
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ClinicalTrials.gov Identifier: NCT01582490 |
Recruitment Status
:
Completed
First Posted
: April 20, 2012
Results First Posted
: July 2, 2014
Last Update Posted
: July 2, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mammoplasty Postoperative Pain | Drug: Instillation - EXPAREL Drug: Infiltration - EXPAREL | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | April 2012 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Infiltration - 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.
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Drug: Instillation - EXPAREL
Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
Other Name: bupivacaine liposomal injectable suspension
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Experimental: Instillation - 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.
|
Drug: Infiltration - EXPAREL
IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
Other Name: bupivacaine liposomal injectable suspension
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- Duration of Analgesia [ Time Frame: 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.
- Total Postsurgical Opioid Consumption in the Surgical Center [ Time Frame: 10 days ]Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.
- Pain Intensity Assessment Upon Waking in the PACU [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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."
- Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 [ Time Frame: 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."

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582490
United States, Massachusetts | |
Steward St. Elizabeth's Medical Center | |
Brighton, Massachusetts, United States, 02135 |
Principal Investigator: | Daniel Del Vecchio, MD | Steward Research |
Responsible Party: | Pacira Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT01582490 History of Changes |
Other Study ID Numbers: |
MA402S23B901 |
First Posted: | April 20, 2012 Key Record Dates |
Results First Posted: | July 2, 2014 |
Last Update Posted: | July 2, 2014 |
Last Verified: | May 2014 |
Keywords provided by Pacira Pharmaceuticals, Inc:
Mammoplasty Postoperative pain Analgesia |
Additional relevant MeSH terms:
Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms |
Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |