Clinical trial NCT01509807: A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retraction of Colostomy
Keywords: Ileostomy reversal
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Registrat-Mapi
First posted: 2012-01-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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).

Primary outcomes:
measure: Total Opioid Burden
timeFrame: Wound closure to time the discharge order is written or Day 30, whichever is sooner
measure: Health Economic Benefits - Total Cost of Hospitalization
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
measure: Health Economic Benefit - Length of Stay
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Secondary outcomes:
measure: Incidence of Opioid-related Adverse Events
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
measure: Patient Satisfaction With Postsurgical Analgesia
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
measure: Patient Discharged From the Hospital for at Least 3 Days
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
measure: Readmission to Hospital Since Discharge
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
measure: Make Unplanned VIsit(s) With Any Healthcare Providers
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
measure: Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
measure: Experienced Any Health Problems or Changed in Health Since Hospital Discharge
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona College of Medicine
state: Arizona
city: Orlando
country: United States
facility: Florida Hospital d/b/a Colon & Rectal Surgery Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida, Tampa, FL
name: Jorge Marcet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona, Tucson, AZ
name: Valentine Nfonsam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Hospital, Orlando, FL.
name: Sergio Larach, MD
role: PRINCIPAL_INVESTIGATOR
References: