The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.
Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
EXPAREL 266 mg (undiluted)
EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.
Steward St. Elizabeth's
Brighton, Massachusetts, United States
The Duration of Abdominal Analgesia From Infiltration Into the TAP
Time frame: First postsurgical administration of an opioid
Subject Reported Postsurgical Pain
11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)
Time frame: 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP
Physician/Healthcare Professional Assessed Postsurgical Pain
11-point NRS (0-10, 0=no pain, 10=worst possible pain)
Time frame: 1, 2, 6, 12, 24 hours after TAP
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
Number of pills
Time frame: 48, 72, 96 hours
Incidence of Prespecified Opioid-related Adverse Events
Number of subjects
Time frame: Until hospital discharge order was written, anticipated at 24 hours.
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)
Time frame: 24 hours, 72 hours, and day 10
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