A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504
Condition: Retraction of Colostomy
Intervention: IV morphine sulfate or Sponsor-approved equivalent; EXPAREL
Intervention description: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.; Patients enrolled 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 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.
Intervention MeSH terms: Morphine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ileostomy reversal

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age and 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 lest 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).