Adult Patients Undergoing Open Colectomy MA402S23B303

Study Overview
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Brief Summary
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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
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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.

Official 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

Conditions
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Bowel Obstruction

Intervention / Treatment
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* Drug: IV morphine sulfate
* Drug: EXPAREL (bupivacaine liposome injectable suspension)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV morphine sulfate<br>Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need. | Drug: IV morphine sulfate<br>* 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.<br>* Other names: morphine sulfate (or Sponsor-approved equivalent);|
| Experimental: EXPAREL (bupivacaine liposome injectable suspension)<br>EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc. | Drug: EXPAREL (bupivacaine liposome injectable suspension)<br>* 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.<br>* Other names: bupivacaine free base;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Health Economic Benefits - Total Cost of Hospitalization | Total cost of hospitalization until the time 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. | 
| Health Economic Benefits - Length of Stay | 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. | Up to Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Predefined Opioid-related Adverse Events | The 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open colectomy