Status:
COMPLETED
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Collaborating Sponsors:
Registrat-Mapi
Conditions:
Retraction of Colostomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 po...
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 (bupivacain...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01509807
Start Date
January 1 2012
End Date
October 1 2012
Last Update
April 7 2014
Active Locations (3)
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1
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
2
Florida Hospital d/b/a Colon & Rectal Surgery Center
Orlando, Florida, United States, 32804
3
University of South Florida
Tampa, Florida, United States, 33606