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Completed

NCT Number: NCT01582490

Study of EXPAREL in Patients Undergoing Breast Augmentation

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).

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Key information

Conditions

Mammoplasty Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Steward St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Instillation - EXPAREL

Drug

Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Other names: bupivacaine liposomal injectable suspension

Infiltration - EXPAREL

Drug

IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Other names: bupivacaine liposomal injectable suspension

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total Postsurgical Opioid Consumption in the Surgical Center

    Time frame: 10 days

    Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.

  2. 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.

  3. 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.

  4. 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,

  5. Incidence of Opioid-Related Adverse Events

    Time frame: Through 10 Days Post Surgery

    The incidence of adverse events that were assessed as opioid-related

  6. 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."

  7. 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."

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2012
Registry last updated
Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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