This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospital costs.
This is a Phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing laparoscopic colectomy with general anesthesia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
122
Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU is less than one hour.
Patients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. All patients will be offered rescue analgesia, as needed.
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Miami, Dept. Anesthesiology
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Albany Medical College
Albany, New York, United States
Total Opioid Burden
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Health Economic Benefits - Total Cost of Hospitalization
Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Health Economic Benefits - Length of Stay (LOS)
Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
Time frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner
Incidence of Opioid-related Adverse Events
Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
Time frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.
Patient Satisfaction With Pain Treatment After Surgery
Responses to question pertaining to patient satisfaction with pain treatment
Time frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.
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The Ohio State University Medical Center
Columbus, Ohio, United States
Methodist Hospital
Houston, Texas, United States