A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy
Condition: Bowel Obstruction
MeSH terms: Intestinal Obstruction
Intervention: IV morphine sulfate or Sponsor-approved equivalent; EXPAREL
Intervention description: 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.
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: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: laparoscopic colectomy

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 hospital costs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age.

          -  Patients scheduled to undergo laparoscopic segmental colectomy with planned primary
             anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse
             colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a
             planned laparoscopic colectomy to an open colectomy were not eligible.)

          -  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
             or who are unwilling to use acceptable means of contraception for at least 1 month
             before and 1 month after dosing. Acceptable means of contraception include hormonal
             contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g.,
             condoms with spermicide), intrauterine device, lifestyle with a personal choice of
             abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with
             a partner who has had a vasectomy.

          -  Patients with any psychiatric, psychological, or other condition that the Investigator
             feels may make the patient an inappropriate candidate for this clinical study.

          -  Participation in an 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, a patient was ineligible if he or she met the following criteria during
        surgery:

          -  Patients who had any concurrent surgical procedure.

          -  Patients with unplanned multiple segmental resections of large intestine.

          -  Patients who converted from laparoscopic-assisted colectomy to traditional open
             colectomy.

          -  Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the
             like placed.

          -  Patients who received intraoperative administration of opioids (other than fentanyl or
             analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.

          -  Patients who received Entereg.