Bowel Obstruction Clinical Trial
— IMPROVE-OpenOfficial 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
Verified date | January 2014 |
Source | Pacira Pharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL therefore possibly reducing total hospitalization costs.
Status | Terminated |
Enrollment | 2 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female, 18 years of age and 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 study 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 any 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. In addition, the patient will be ineligible if he or she meets the following criteria during surgery: - Patients with unplanned multiple segmental resections of 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 any other analgesic, local anesthetics, or anti-inflammatory agents. - Patients who receive Entereg(R). - Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Pacira Pharmaceuticals, Inc | Registrat-Mapi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Opioid Burden | Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner. | Wound closure to time hospital discharge order written or Day 30, whichever is sooner | Yes |
Primary | Health Economic Benefit | 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. |
Wound closure to time hospital discharge order written or Day 30, whichever is sooner. | No |
Secondary | Incidence of Opioid-related Adverse Events | 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. | 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 | Yes |
Secondary | Patient Satisfaction With Postsurgical Analgesia | Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge. | 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 | Yes |
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