Conditions: Bowel Obstruction
Keywords: open colectomy colectomy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5
Healthy volunteers: no

Brief summary:
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

Detailed description:
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 extended-release injectable suspension), compared with postsurgical administration of standardized intravenous (IV) morphine sulfate, for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Arms:
arm 1: morphine sulfate (or Sponsor-approved equivalent) arm 2: EXPAREL (bupivacaine liposome injectable suspension)

Interventions: intervention 1: IV morphine sulfate intervention 2: EXPAREL (bupivacaine liposome injectable suspension)
Intervention descriptions: intervention 1: Patients in this group will receive IV morphine sulfate via 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 the floor if the stay in the PACU is less than 1 hour. intervention 2: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a 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.

Protocol document: