Title
Adult Patients Undergoing Open Colectomy MA402S23B303
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
Phase
Phase 4Lead Sponsor
Pacira PharmaceuticalsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Bowel ObstructionIntervention/Treatment
levobupivacaine morphine ...Study Participants
42This study is designed to compare the standard of care against EXPAREL(R) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.
This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.
Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.
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.
Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need.
EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc.
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 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 an 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 who have any concurrent surgical procedure. 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).
| Event Type | Organ System | Event Term | PCA/Opioid Group | EXPAREL Group |
|---|
Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.
Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
The incidence of predefined opioid-related adverse events
