Status:
COMPLETED
Adult Patients Undergoing Open Colectomy MA402S23B303
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Collaborating Sponsors:
Registrat-Mapi
Conditions:
Bowel Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 cost...
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 compared wi...
Eligibility Criteria
Inclusion
- 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.
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.
- 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).
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01507246
Start Date
December 1 2011
End Date
August 1 2012
Last Update
May 8 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Atlanta Colon and Rectal Surgery
Riverdale, Georgia, United States, 30274