The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.
The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures; primary endpoint signal seen during pre-specified interim analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
67
Florida Hospital
Winter Park, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4
Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4
Time frame: From surgery through 4 days postsurgery
Overall Benefit of Analgesic Score (OBAS) at Day 3
Severity of postsurgical pain, satisfaction with pain management, and impact of opioid-related symptom distress measured using the Overall Benefit of Analgesic Score (OBAS) - primary endpoint is mean difference in OBAS at Day 3. (0=minimal pain and 4=maximum imaginable pain)
Time frame: Postsurgical day 1 through day 3
Extent and Degree of Anesthetic Blockade
Extent and degree of anesthetic blockage measured using a 5-point sensation scale.
Time frame: Prior to TAP, immediately postoperatively, and daily through discharge or Day 4
Severity of Postsurgical Pain
Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10).
Time frame: Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)
Quality of Recovery
Measured using the Quality of Recovery 15 questionnaire (QoR-15)
Time frame: Daily through Post Op Day 4
Frequency of Patient Calls Post-discharge
Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits
Time frame: Post-discharge through 4 days postsurgery
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University of Louisville
Louisville, Kentucky, United States
Berkshire Medical Center
Pittsfield, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
Fairview Hospital
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
...and 3 more locations