A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301

PHASE4TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Bowel Obstruction
Interventions
DRUG

morphine sulfate

Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to the floor if the stay in the PACU is less than 1 hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.

DRUG

bupivacaine liposome extended-release injectable suspension

"Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."

Trial Locations (1)

43210

The Ohio State University, Columbus

Sponsors
All Listed Sponsors
lead

Pacira Pharmaceuticals, Inc

INDUSTRY

collaborator

Registrat-Mapi

OTHER