A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) 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 (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Official 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 Ileostomy Reversal

Conditions
-----------------
Retraction of Colostomy

Intervention / Treatment
-----------------
* Drug: IV morphine sulfate or Sponsor-approved equivalent
* Drug: EXPAREL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years of age and older Patients scheduled to undergo ileostomy reversal 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 or who are unwilling to use acceptable means of contraception for at lest one month before and one month after dosing. 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. In addition, the patient will be ineligible if he/she meets the following criteria during surgery: Patients who have any concurrent surgical procedure. 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC) | Drug: IV morphine sulfate or Sponsor-approved equivalent<br>* Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.<br>|
| Experimental: Group 2<br>EXPAREL (bupivacaine liposome injectable suspension) | Drug: EXPAREL<br>* Patients enrolled 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.<br>* Other names: bupivacaine liposome injectable suspension;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Burden | Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner. | Wound closure to time the discharge order is written or Day 30, whichever is sooner | 
| Health Economic Benefits - Total Cost of Hospitalization | 1) 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 is written or Day 30, whichever is sooner. | 
| Health Economic Benefit - Length of Stay | Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Opioid-related Adverse Events | Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 
| Patient Satisfaction With Postsurgical Analgesia | Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 
| Patient Discharged From the Hospital for at Least 3 Days | Yes, if patient was discharged from the hospital for at least 3 days; no, if patient was not discharged for at least 3 day; not reported if appropriate | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 
| Readmission to Hospital Since Discharge | Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 
| Make Unplanned VIsit(s) With Any Healthcare Providers | Yes, if patient made an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 
| Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery | Yes, if patient contacted or attempted to contact surgeon/doctor to discuss recovery after surgery; no, if patient did not contact or attempt contact; not reported if applicable. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 
| Experienced Any Health Problems or Changed in Health Since Hospital Discharge | Yes, if patient experienced any health problems or changes in health since hospital discharge; no, if patient did not experience health problems or changes since hospital discharge; not reported, if applicable. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ileostomy reversal