Overview

A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301

Status:
Terminated
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
Summary
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL therefore possibly reducing total hospitalization costs.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Collaborator:
Registrat-Mapi
Treatments:
Bupivacaine
Morphine
Criteria
Inclusion Criteria:

- Male or female, 18 years of age and older.

- Patients scheduled to undergo open segmental colectomy with planned primary
anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse
colon, left hemicolectomy, or sigmoidectomy.

- Ability to provide informed consent, adhere to study visit schedule, and complete all
study 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.

- 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 a 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.

In addition, the patient will be ineligible if he or she meets the following criteria
during surgery:

- Patients with unplanned multiple segmental resections of large intestine.

- Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the
like placed.

- 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).

- Patients who undergo any concurrent surgical procedure during the ileostomy reversal
surgery.