A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501 (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: Group 1 Standard of Care; Drug: Group 2 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 or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Cleveland Clinic Ohio

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 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 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 Standard of Care; IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump	Drug: Group 1 Standard of Care; Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
ACTIVE_COMPARATOR: Group 2 EXPAREL; bupivacaine liposome injectable suspension.	Drug: Group 2 EXPAREL; Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc 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 hospital discharge order is written or Day 30, whichever is sooner
Health Economic Benefits	Total cost of hospitalization until the time the 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 (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.	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 one question pertaining to patient satisfaction with postsurgical analgesia	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Patient Discharged From Hospital for at Least 3 Days	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.	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Patient Made Unplanned Visit(s) With Any Healthcare Providers	Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery	Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable.	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Experienced Health Problems or Changes in Health Since Hospital Discharge	Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable	Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Time to First Opioid Administration	Time in hours to first opioid administration	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: Marylise Boutros, M.D., Cleveland Clinic Florida

Publications and helpful links

General Publications

• Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: March 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 12, 2012
• First Posted (ESTIMATE): January 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 6, 2014
• Last Update Submitted That Met QC Criteria: January 19, 2014
• Last Verified: January 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; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MA402S23B501