IMPROVE-IRA 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
IV morphine sulfate or Sponsor-approved equivalent
+ EXPAREL
Services Research Study
Summary
Study start date: January 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
University of Arizona College of Medicine
Tucson, United StatesOpen University of Arizona College of Medicine in Google MapsFlorida Hospital d/b/a Colon & Rectal Surgery Center
Orlando, United StatesUniversity of South Florida
Tampa, United States