A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B302 (IMPROVE-Open)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01507233|
Recruitment Status : Terminated (Slow enrollment.)
First Posted : January 10, 2012
Results First Posted : March 6, 2014
Last Update Posted : March 6, 2014
|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 :||5 participants|
|Intervention Model:||Parallel 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 :||May 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Active Comparator: IV morphine sulfate
morphine sulfate (or Sponsor-approved equivalent)
Drug: IV morphine sulfate
Patients in this group will receive IV morphine sulfate 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.
Other Name: morphine sulfate (or Sponsor-approved equivalent)
EXPAREL (bupivacaine liposome injectable suspension)
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, a 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 [ Time Frame: Wound closure to Day 30 ]
- Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
- Length of stay (LOS), recorded in hours, 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 Opioid-related Adverse Events and Patient Satisfaction With Postsurgical Analgesia. [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ]
- Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
- Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507233
|United States, Florida|
|University of Miami, Dept of Anesthesiology|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Keith Candiotti, M.D.||University of Miami|