A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504

PHASE4CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Retraction of Colostomy
Interventions
DRUG

IV morphine sulfate or Sponsor-approved equivalent

Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.

DRUG

EXPAREL

Patients enrolled 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

Trial Locations (3)

32804

Florida Hospital d/b/a Colon & Rectal Surgery Center, Orlando

33606

University of South Florida, Tampa

85724

University of Arizona College of Medicine, Tucson

Sponsors
All Listed Sponsors
collaborator

Registrat-Mapi

OTHER

lead

Pacira Pharmaceuticals, Inc

INDUSTRY

NCT01509807 - A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504 | Biotech Hunter | Biotech Hunter