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TERMINATEDPHASE4

A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy

A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)

NCT02058290•Pacira Pharmaceuticals, Inc

View on ClinicalTrials.gov

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 hospital 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 or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing laparoscopic colectomy with general anesthesia.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, at least 18 years of age.
•Patients who had any concurrent surgical procedure.
•Patients with unplanned multiple segmental resections of large intestine.
•Patients who converted from laparoscopic-assisted colectomy to traditional open colectomy.
•Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
•Patients who received intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
•Patients who received Entereg.

Exclusion Criteria

•Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.
•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 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
•Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
•Participation in an EXPAREL study within the last 30 days.
•Patients who have received any 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.

Locations (6)

Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Miami, Dept. Anesthesiology

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Albany Medical College

Albany, New York, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Methodist Hospital

Houston, Texas, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

September 1, 2012

Completion Date

February 1, 2013

Last Updated

May 14, 2014

Enrollment

122

ACTUAL participants

Conditions

Bowel Obstruction

Interventions

IV morphine sulfate or Sponsor-approved equivalent

DRUG

EXPAREL

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy

Inclusion Criteria

Exclusion Criteria

Study About Contrast Media

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