A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501

NCT01509638 | Completed Phase 4 Results

• 1 other identifier: MA402S23B501
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Retraction of Colostomy

Keywords

Ileostomy reversal

Outcome Measures

Primary Outcomes (3)

• Total Opioid Burden

  Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.

  Wound closure to time hospital discharge order is written or Day 30, whichever is sooner

• Health Economic Benefits

  Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.

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

• Health Economic Benefit

  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.

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

Secondary Outcomes (7)

• Incidence of Opioid-related Adverse Events

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

• Patient Satisfaction With Postsurgical Analgesia

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

• Patient Discharged From Hospital for at Least 3 Days

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

• Patient Made Unplanned Visit(s) With Any Healthcare Providers

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

• Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery

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

Study Arms (2)

Group 1 Standard of Care

ACTIVE COMPARATOR

IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump

Drug: Group 1 Standard of Care

Group 2 EXPAREL

ACTIVE COMPARATOR

bupivacaine liposome injectable suspension.

Drug: Group 2 EXPAREL

Interventions

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 1 Standard of Care

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.

Also known as: bupivacaine liposome injectable suspension

Group 2 EXPAREL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead
• Registrat-Mapi: collaborator

Study Sites (2)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Cleveland Clinic Ohio

Beachwood, Ohio, 44122, United States

Location

Related Publications (1)

• 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.

  PMID: 25018650 DERIVED

Results Point of Contact

• Title: Marylise Boutrous, MD
• Organization: Cleveland Clinic Florida

canedoj@ccf.org

954-659-5000

Study Officials

• Marylise Boutros, M.D.

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: January 13, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 6, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-01

Locations

US (2)