Study of EXPAREL in Patients Undergoing Breast Augmentation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Safety and Efficacy of EXPAREL® (Bupivacaine Liposome Injectable Suspension) When Administered Via Infiltration Versus Instillation in Subjects Undergoing Bilateral Augmentation Mammoplasty

Conditions
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Mammoplasty, Postoperative Pain

Intervention / Treatment
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* Drug: Instillation - EXPAREL
* Drug: Infiltration - EXPAREL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infiltration - EXPAREL<br>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. | Drug: Instillation - EXPAREL<br>* Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.<br>* Other names: bupivacaine liposomal injectable suspension;|
| Experimental: Instillation - EXPAREL<br>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<br>* IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.<br>* Other names: bupivacaine liposomal injectable suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Postsurgical Opioid Consumption in the Surgical Center | Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group. | 10 days | 
| 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 | 
| 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 | 
| 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 | 
| Incidence of Opioid-Related Adverse Events | The incidence of adverse events that were assessed as opioid-related | Through 10 Days Post Surgery | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mammoplasty, Postoperative pain, Analgesia