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

• ClinicalTrials.gov Identifier: NCT01509638
• Recruitment Status: Completed
• First Posted: January 13, 2012
• Results First Posted: March 6, 2014
• Last Update Posted: March 6, 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: Group 1 Standard of Care; Drug: Group 2 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 or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 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: March 2012
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

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 Name: bupivacaine liposome injectable suspension

Outcome Measures

Primary Outcome Measures :

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 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 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

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 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT01509638
• Other Study ID Numbers: MA402S23B501
• First Posted: January 13, 2012
• Results First Posted: March 6, 2014
• Last Update Posted: March 6, 2014
• Last Verified: January 2014

Keywords provided by Pacira Pharmaceuticals, Inc:

Ileostomy reversal

Additional relevant MeSH terms:

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