A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501

Phase 4

Completed

Conditions: Retraction of Colostomy

Interventions: Drug: Group 1 Standard of Care
Drug: Group 2 EXPAREL

Registration Number: NCT01509638

Lead Sponsor: Pacira Pharmaceuticals, Inc

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 hospitalization 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 ileostomy reversal with general anesthesia.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 47

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 Standard of Care	Group 1 Standard of Care	IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 2 EXPAREL	Group 2 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	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.
Health Economic Benefit	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Opioid-related Adverse Events	Wound closure to 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 Postsurgical Analgesia	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	Responses to one question pertaining to patient satisfaction with postsurgical analgesia
Patient Discharged From Hospital for at Least 3 Days	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	Yes, if patient discharged from hospital for at least 3 days; no, if patient not discharged from hospital for at least 3 day; not reported, if applicable.
Patient Made Unplanned Visit(s) With Any Healthcare Providers	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable
Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable.
Experienced Health Problems or Changes in Health Since Hospital Discharge	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable
Time to First Opioid Administration	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.	Time in hours to first opioid administration