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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

October 24, 2011
January 19, 2014
March 2012
October 2012   (final data collection date for primary outcome measure)
  • 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.
  • Total opioid burden [ Time Frame: Wound closure to time hospital discharge order 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 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 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.
Complete list of historical versions of study NCT01509638 on ClinicalTrials.gov Archive Site
  • 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
  • Incidence of opioid related adverse events and patient satisfaction with postsurgical analgesia [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    Incidence of opioid-related adverse events definded as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
  • Incidence of opioid related adverse events and patient satisfaction with postsurgical analgesia [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.
Not Provided
Not Provided
 
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Retraction of Colostomy
  • Drug: Group 1 Standard of Care
    Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
  • 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
  • Active Comparator: Group 1 Standard of Care
    IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
    Intervention: Drug: Group 1 Standard of Care
  • Active Comparator: Group 2 EXPAREL
    bupivacaine liposome injectable suspension.
    Intervention: Drug: Group 2 EXPAREL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
October 2012
October 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01509638
MA402S23B501
No
Pacira Pharmaceuticals, Inc
Pacira Pharmaceuticals, Inc
Registrat-Mapi
Principal Investigator: Marylise Boutros, M.D. Cleveland Clinic Florida
Pacira Pharmaceuticals, Inc
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP