A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap)
|ClinicalTrials.gov Identifier: NCT02058290|
Recruitment Status : Terminated (Slower than expected enrollment)
First Posted : February 10, 2014
Results First Posted : May 14, 2014
Last Update Posted : May 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bowel Obstruction||Drug: IV morphine sulfate or Sponsor-approved equivalent Drug: EXPAREL||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 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(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||February 2013|
Active Comparator: IV Morphine Sulfate or Sponsor-approved Equivalent
Standard of Care (SOC)
Drug: IV morphine sulfate or Sponsor-approved equivalent
Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a 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 a floor if the stay in the PACU is less than one hour.
EXPAREL (bupivacaine liposome injectable suspension)
Patients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc 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 liposome injectable suspension
- Total Opioid Burden [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]Total opioid consumed (IV and PO) postsurgically until 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 is written or Day 30, whichever is sooner. ]Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.
- Health Economic Benefits - Length of Stay (LOS) [ Time Frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner ]Length of stay, recorded in days, 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: Wound closure at time hospital discharge order is 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.
- Patient Satisfaction With Pain Treatment After Surgery [ Time Frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner. ]Responses to question pertaining to patient satisfaction with pain treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058290
|United States, District of Columbia|
|Washington Hospital Center|
|Washington DC, District of Columbia, United States, 20010|
|United States, Florida|
|University of Miami, Dept. Anesthesiology|
|Miami, Florida, United States, 33136|
|Tampa General Hospital|
|Tampa, Florida, United States, 33606|
|United States, New York|
|Albany Medical College|
|Albany, New York, United States, 12208|
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Edward C Lee, MD||Albany Medical College|
|Principal Investigator:||Keith Candiotti, MD||University of Miami|
|Principal Investigator:||Sergio Bergese, MD||Ohio State University|
|Principal Investigator:||Eric M Haas, MD||The Methodist Hospital System|
|Principal Investigator:||Jorge Marcet, MD||Tampa General Hospital|
|Principal Investigator:||Anjali Kumar, MD||Washington Hospital Center|