A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501

PHASE4CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Retraction of Colostomy
Interventions
DRUG

Group 1 Standard of Care

Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.

DRUG

Group 2 EXPAREL

Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc 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 (2)

33331

Cleveland Clinic Florida, Weston

44122

Cleveland Clinic Ohio, Beachwood

Sponsors
All Listed Sponsors
collaborator

Registrat-Mapi

OTHER

lead

Pacira Pharmaceuticals, Inc

INDUSTRY