Adult Patients Undergoing Open Colectomy MA402S23B303

Completed · Phase 4

Conditions studied: Bowel Obstruction

In brief

This study is designed to compare the standard of care against EXPAREL(R) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

Key facts

Study ID

NCT01507246

Run by

Pacira Pharmaceuticals, Inc

People needed

42

Starts

2011-12-01

Expected to finish

2012-08-01

Last updated by the study team

2013-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 assessments.

You may not qualify if…

• 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 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.
• Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery
• In addition, the patient will be ineligible if he/she meets the following criteria during surgery:
• Patients who have any concurrent surgical procedure.
• Patients with unplanned multiple segmental resections or 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 an other analgesic, local anesthetics, or anti-inflammatory agents.
• Patients who receive Entereg(R).

Where it is running

• Atlanta Colon and Rectal Surgery — Riverdale, Georgia, United States

Full record on ClinicalTrials.gov

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