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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
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.
Time frame: 10 days
Total Postsurgical Opioid Consumption in the Surgical Center
Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.
Time frame: 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.
Time frame: 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.
Time frame: 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,
Time frame: At the time of hospital discharge
Incidence of Opioid-Related Adverse Events
The incidence of adverse events that were assessed as opioid-related
Time frame: Through 10 Days Post Surgery
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge
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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
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."
Time frame: Day 10 after surgery