A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504 (IMPROVE-IR)

A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of BupiVacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal

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.

Study Overview

• Status: Completed
• Conditions: Retraction of Colostomy
• Intervention / Treatment: Drug: IV morphine sulfate or Sponsor-approved equivalent; Drug: EXPAREL

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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona College of Medicine
  • Florida
    • Orlando, Florida, United States, 32804
      • Florida Hospital d/b/a Colon & Rectal Surgery Center
    • Tampa, Florida, United States, 33606
      • University of South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1; IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)	Drug: IV morphine sulfate or Sponsor-approved equivalent; Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
EXPERIMENTAL: Group 2; EXPAREL (bupivacaine liposome injectable suspension)	Drug: EXPAREL; 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.; Other Names: bupivacaine liposome injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Burden	Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.	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.	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	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Readmission to Hospital Since Discharge	Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate.	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Make Unplanned VIsit(s) With Any Healthcare Providers	Yes, if patient made an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery	Yes, if patient contacted or attempted to contact surgeon/doctor to discuss recovery after surgery; no, if patient did not contact or attempt contact; not reported if applicable.	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Experienced Any Health Problems or Changed in Health Since Hospital Discharge	Yes, if patient experienced any health problems or changes in health since hospital discharge; no, if patient did not experience health problems or changes since hospital discharge; not reported, if applicable.	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc
• Collaborators: Registrat-Mapi
• Investigators: Principal Investigator: Jorge Marcet, MD, University of South Florida, Tampa, FL; Principal Investigator: Valentine Nfonsam, MD, University of Arizona, Tucson, AZ; Principal Investigator: Sergio Larach, MD, Florida Hospital, Orlando, FL.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: January 10, 2012
• First Posted (ESTIMATE): January 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2014
• Last Update Submitted That Met QC Criteria: March 9, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Ileostomy reversal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: MA402S23B504