A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301
Condition: Bowel Obstruction
MeSH terms: Intestinal Obstruction
Intervention: morphine sulfate; bupivacaine liposome extended-release injectable suspension
Intervention description: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) 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. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.; 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 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.
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: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: open colectomy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age and older.

          -  Patients scheduled to undergo open segmental colectomy with planned primary
             anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse
             colon, left hemicolectomy, or sigmoidectomy.

          -  Ability to provide informed consent, adhere to study visit schedule, and complete all
             study 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.

          -  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 a EXPAREL study within the last 30 days.

          -  Patients who have received any 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 or she meets the following criteria
        during surgery:

          -  Patients with unplanned multiple segmental resections of large intestine.

          -  Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the
             like placed.

          -  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).

          -  Patients who undergo any concurrent surgical procedure during the ileostomy reversal
             surgery.