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

• ClinicalTrials.gov Identifier: NCT01509807
• Recruitment Status: Completed
• First Posted: January 13, 2012
• Results First Posted: April 7, 2014
• Last Update Posted: April 7, 2014
• Sponsor: Pacira Pharmaceuticals, Inc
• Collaborator: Registrat-Mapi
• Information provided by (Responsible Party): Pacira Pharmaceuticals, Inc

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Retraction of Colostomy	Drug: IV morphine sulfate or Sponsor-approved equivalent; Drug: EXPAREL	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: January 2012
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

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 Name: bupivacaine liposome injectable suspension

Outcome Measures

Primary Outcome Measures :

1. Total Opioid Burden [ Time Frame: Wound closure to time the 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 - Total Cost of Hospitalization [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]
   1) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
3. Health Economic Benefit - Length of Stay [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]
   Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner

Secondary Outcome Measures :

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 question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied.
3. Patient Discharged From the 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 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
4. Readmission to Hospital Since Discharge [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]
   Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate.
5. Make 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 an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable
6. Contact or Attempt 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 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.
7. Experienced Any Health Problems or Changed in Health Since Hospital Discharge [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

United States, Arizona

University of Arizona College of Medicine

Tucson, Arizona, United States, 85724

United States, Florida

Florida Hospital d/b/a Colon & Rectal Surgery Center

Orlando, Florida, United States, 32804

University of South Florida

Tampa, Florida, United States, 33606

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

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.

More Information

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT01509807
• Other Study ID Numbers: MA402S23B504
• First Posted: January 13, 2012
• Results First Posted: April 7, 2014
• Last Update Posted: April 7, 2014
• Last Verified: March 2014

Keywords provided by Pacira Pharmaceuticals, Inc:

Ileostomy reversal

Additional relevant MeSH terms:

Morphine; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Opioid; Narcotics; Analgesics