A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B302
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | March 2012 |
| End Date: | November 2013 |
An Extended Pain Relief Trial Utilizing the Infiltration of a Long Acting Multivesicular Liposome Formulation of Bupivacaine EXPAREL: A Phase 3b Health Economic Trial in Adult Patients Undergoing Open Colectomy (IMPROVE - Open Colectomy)
This study is designed to compare the standard of care against SKY0402 (bupivacaine liposome
extended-release injectable suspension) to determine if total opioid consumption is reduced
when using SKY0402, therefore possibly reducing total hospitalization costs.
This is a phase 3b, prospective, sequential, open-label study designed to evaluate the
efficacy, safety, and health economic benefits of intraoperative local wound infiltration
with SKY0402 (bupivacaine liposome extended-release injectable suspension), compared with
postsurgical administration of standardized intravenous (IV) morphine sulfate, for
postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.
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 SKY0402 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.
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 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).
We found this trial at
1
site
Click here to add this to my saved trials
