A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504

Pacira Pharmaceuticals, Inc33 enrolled

Overview

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.

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 for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Retraction of Colostomy

Interventions

IV morphine sulfate or Sponsor-approved equivalentDRUG

Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.

EXPARELDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (3)

University of Arizona College of Medicine

Tucson, Arizona, United States

Florida Hospital d/b/a Colon & Rectal Surgery Center

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Outcomes

Primary Outcomes

Total Opioid Burden

Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.

Time frame: Wound closure to time the discharge order is written or Day 30, whichever is sooner

Health Economic Benefits - Total Cost of Hospitalization

1\) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.

Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

Health Economic Benefit - Length of Stay

Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner

Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

Secondary Outcomes

Incidence of Opioid-related Adverse Events

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.

Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

Patient Satisfaction With Postsurgical Analgesia

Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied.

Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

Patient Discharged From the Hospital for at Least 3 Days

Yes, if patient was discharged from the hospital for at least 3 days; no, if patient was not discharged for at least 3 day; not reported if appropriate

Data from ClinicalTrials.gov

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