A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301 (IMPROVE-Open)
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|ClinicalTrials.gov Identifier: NCT01507220|
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: morphine sulfate Drug: bupivacaine liposome extended-release injectable suspension||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 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 :||March 2012|
|Primary Completion Date :||July 2012|
|Study Completion Date :||July 2012|
Active Comparator: Morphine sulfate
morphine sulfate (or Sponsor-approved equivalent)
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.
Other Name: morphine sulfate (or Sponsor-approved equivalent)
EXPAREL (bupivacaine liposome extended-release injectable suspension)
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.
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 Benefit [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ]
- Total cost of hospitalization to 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 [ Time Frame: From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner ]
Incidence of opioid-related adverse events is defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
- Patient Satisfaction With Postsurgical Analgesia [ Time Frame: From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner ]Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507220
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Sergio Bergese, MD||Ohio State University|