A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504

NCT01509807 | Completed Phase 4 Results

• 1 other identifier: MA402S23B504
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

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 the discharge order is written or Day 30, whichever is sooner

• Health Economic Benefits - Total Cost of Hospitalization

  1\) Total cost of hospitalization until the time 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 Benefit - Length of Stay

  Time from completion of wound closure until hospital discharge written or through Day 30, whichever was 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 the Hospital for at Least 3 Days

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

• Readmission to Hospital Since Discharge

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

• Make Unplanned VIsit(s) With Any Healthcare Providers

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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)

Drug: IV morphine sulfate or Sponsor-approved equivalent

Group 2

EXPERIMENTAL

EXPAREL (bupivacaine liposome injectable suspension)

Drug: EXPAREL

Interventions

IV morphine sulfate or Sponsor-approved equivalent DRUG

Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.

Group 1

EXPAREL DRUG

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.

Also known as: bupivacaine liposome injectable suspension

Group 2

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 and 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 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).

Sponsors & Collaborators

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

Study Sites (3)

University of Arizona College of Medicine

Tucson, Arizona, 85724, United States

Location

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

Orlando, Florida, 32804, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Jorge Marcet, MD
• Organization: University of South Florida

jmarcet@health.usf.edu

813-844-4545

Study Officials

• 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.

  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: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-03

Locations

US (3)