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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01507233 |
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Date of registration:
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24/10/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B302
IMPROVE-Open |
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Scientific title:
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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 |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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5 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01507233 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Keith Candiotti, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Miami |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female, 18 years of age or older.
- Patients scheduled to undergo open segmental colectomy with planned primary
anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse
colon, left hemicolectomy, or sigmoidectomy.
- Ability to provide informed consent, adhere to study visit schedule, and complete all
assessments.
Exclusion Criteria:
- Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance
to any local anesthetic, opioid, or propofol.
- Patients who abuse alcohol or other drug substance.
- Patients with severe hepatic impairment.
- Patients currently pregnant or who may become pregnant during the course of the study.
- Patients with any psychiatric, psychological, or other condition that the Investigator
feels may make the patient an inappropriate candidate for this clinical study.
- Patients who have participated in a EXPAREL study within the last 30 days.
- Patients who have received an investigational drug within 30 days prior to study drug
administration, or planned administration of another investigational product or
procedure during the patient's participation in this study.
- Patients who undergo any concurrent surgical procedure during the ileostomy reversal
surgery.
In addition, the patient will be ineligible if he/she meets the following criteria during
surgery:
- Patients with unplanned multiple segmental resections or large intestine.
- Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the
like placed.
- Patients who receive intraoperative administration of opioids (other than fentanyl or
analogs) or an other analgesic, local anesthetics, or anti-inflammatory agents.
- Patients who receive Entereg(R).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bowel Obstruction
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Intervention(s)
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Drug: EXPAREL (bupivacaine liposome injectable suspension)
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Drug: IV morphine sulfate
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Primary Outcome(s)
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Health Economic Benefits
[Time Frame: Wound closure to Day 30]
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Total Opioid Burden
[Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner]
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Secondary Outcome(s)
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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.]
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Secondary ID(s)
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MA402S23B302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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