A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy

Phase 4

Terminated

Interventions: Drug: IV morphine sulfate or Sponsor-approved equivalent
Drug: EXPAREL

Brief 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.

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 injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing laparoscopic colectomy with general anesthesia.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
IV Morphine Sulfate or Sponsor-approved Equivalent	IV morphine sulfate or Sponsor-approved equivalent	Standard of Care (SOC)
EXPAREL	EXPAREL	EXPAREL (bupivacaine liposome injectable suspension)

Primary Outcome Measures

Name	Time	Method
Total Opioid Burden	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Health Economic Benefits - Total Cost of Hospitalization	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.
Health Economic Benefits - Length of Stay (LOS)	Wound closure at time hospital discharge order is written or Day 30, whichever is sooner	Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.

Secondary Outcome Measures

Name	Time	Method
Incidence of Opioid-related Adverse Events	Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.	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.
Patient Satisfaction With Pain Treatment After Surgery	Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.	Responses to question pertaining to patient satisfaction with pain treatment

Locations (6): Methodist Hospital
🇺🇸
Houston, Texas, United States
University of Miami, Dept. Anesthesiology
🇺🇸
Miami, Florida, United States
Tampa General Hospital
🇺🇸
Tampa, Florida, United States
The Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Washington Hospital Center
🇺🇸
Washington DC, District of Columbia, United States
Albany Medical College
🇺🇸
Albany, New York, United States