Adult Patients Undergoing Open Colectomy MA402S23B303

Phase 4

Completed

Interventions: Drug: EXPAREL (bupivacaine liposome injectable suspension)
Drug: IV morphine sulfate

Brief Summary: This 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.

Detailed Description: 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.

Recruitment & 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 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).

Arm && Interventions

Group	Intervention	Description
EXPAREL (bupivacaine liposome injectable suspension)	EXPAREL (bupivacaine liposome injectable suspension)	EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc.
IV morphine sulfate	IV morphine sulfate	Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need.

Primary Outcome Measures

Name	Time	Method
Total Opioid Burden	Wound closure to time hospital discharge order written or Day 30, whichever is sooner	Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.
Health Economic Benefits - Total Cost of Hospitalization	Wound closure to time hospital discharge order written or Day 30, whichever is sooner.	Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
Health Economic Benefits - Length of Stay	Up to Day 30	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Predefined Opioid-related Adverse Events	From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner	The incidence of predefined opioid-related adverse events