A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501 (IMPROVE-IR)

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01509638
First received: October 24, 2011
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Retraction of Colostomy
Drug: Group 1 Standard of Care
Drug: Group 2 EXPAREL
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Total Opioid Burden [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner ] [ Designated as safety issue: Yes ]
    Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.

  • Health Economic Benefits [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
    Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.

  • Health Economic Benefit [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
    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:
  • Incidence of Opioid-related Adverse Events [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    Responses to one question pertaining to patient satisfaction with postsurgical analgesia

  • Patient Discharged From Hospital for at Least 3 Days [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    Time in hours to first opioid administration


Enrollment: 47
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: bupivacaine liposome injectable suspension

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509638

Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Ohio
Cleveland Clinic Ohio
Beachwood, Ohio, United States, 44122
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Registrat-Mapi
Investigators
Principal Investigator: Marylise Boutros, M.D. Cleveland Clinic Florida
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01509638     History of Changes
Other Study ID Numbers: MA402S23B501
Study First Received: October 24, 2011
Results First Received: November 30, 2013
Last Updated: January 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
Ileostomy reversal

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014