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Completed

NCT Number: NCT01509638

A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501

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.

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Key information

Conditions

Retraction of Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic Florida, Weston, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Group 1 Standard of Care

Drug

Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.

Group 2 EXPAREL

Drug

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

Primary outcomes

  1. Total Opioid Burden

    Time frame: 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.

  2. Health Economic Benefits

    Time frame: 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.

  3. Health Economic Benefit

    Time frame: 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 outcomes

  1. Incidence of Opioid-related Adverse Events

    Time frame: 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.

  2. Patient Satisfaction With Postsurgical Analgesia

    Time frame: 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

  3. 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.

    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.

  4. 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.

    Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable

  5. 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.

    Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable.

  6. 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.

    Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable

  7. Time to First Opioid Administration

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

    Time in hours to first opioid administration

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Collaborators

  • Registrat-Mapi

Registry information

Official study 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

Acronym: IMPROVE-IR

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 13, 2012
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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