A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501 (IMPROVE-IR)

• Total opioid burden [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner ] [ Designated as safety issue: Yes ]
  Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
• Health economic benefits [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
  Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.
• Health Economic Benefit [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
  Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.

• Total opioid burden [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner ] [ Designated as safety issue: Yes ]
  Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
• Health economic benefits [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
  Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.
• Health Economic Benefit [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
  Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.

• Incidence of opioid-related adverse events and patient satisfaction with postsurgical analgesia [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
  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.
• Incidence of opioid-related adverse events and patient satisfaction with postsurgical analgesia [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
  Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.

• Incidence of opioid related adverse events and patient satisfaction with postsurgical analgesia [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
  Incidence of opioid-related adverse events definded as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
• Incidence of opioid related adverse events and patient satisfaction with postsurgical analgesia [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
  Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.

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 hospitalization 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 ileostomy reversal with general anesthesia.

• Drug: Group 1 Standard of Care
  Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
• Drug: Group 2 EXPAREL
  Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
  Other Name: bupivacaine liposome injectable suspension

• Active Comparator: Group 1 Standard of Care
  IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
  Intervention: Drug: Group 1 Standard of Care
• Active Comparator: Group 2 EXPAREL
  bupivacaine liposome injectable suspension.
  Intervention: Drug: Group 2 EXPAREL

Inclusion Criteria:

• Male or female, 18 years of age or older.
• Patients scheduled to undergo ileostomy reversal.
• Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.

Exclusion Criteria:

• Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
• Patients who abuse alcohol or other drug substance.
• Patients with severe hepatic impairment.
• Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at least one month before and one month after dosing.
• Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
• Patients who have participated in an EXPAREL study within the last 30 days.
• Patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

In addition, the patient will be ineligible if he/she meets the following criteria during surgery:

• Patients who have any concurrent surgical procedure.
• Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
• Patients who receive Entereg(R).