Adult Patients Undergoing Open Colectomy MA402S23B303 (IMPROVE-Open)
|ClinicalTrials.gov Identifier: NCT01507246|
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : May 8, 2013
Last Update Posted : May 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bowel Obstruction||Drug: IV morphine sulfate Drug: EXPAREL (bupivacaine liposome injectable suspension)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Open Colectomy|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: IV morphine sulfate
Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need.
Drug: IV morphine sulfate
Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.
Other Name: morphine sulfate (or Sponsor-approved equivalent)
Experimental: EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc.
Drug: EXPAREL (bupivacaine liposome 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.
Other Name: bupivacaine free base
- Total Opioid Burden [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner ]Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.
- Health Economic Benefits - Total Cost of Hospitalization [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ]Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
- Health Economic Benefits - Length of Stay [ Time Frame: Up to Day 30 ]Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
- Incidence of Predefined Opioid-related Adverse Events [ Time Frame: From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner ]The incidence of predefined opioid-related adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507246
|United States, Georgia|
|Atlanta Colon and Rectal Surgery|
|Riverdale, Georgia, United States, 30274|
|Principal Investigator:||Stephen Cohen, M.D.||Atlanta Colon and Rectal Surgery|