A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504
- Conditions
- Retraction of Colostomy
- Interventions
- Drug: IV morphine sulfate or Sponsor-approved equivalent
- Registration Number
- NCT01509807
- Lead Sponsor
- Pacira Pharmaceuticals, Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 IV morphine sulfate or Sponsor-approved equivalent IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC) Group 2 EXPAREL EXPAREL (bupivacaine liposome injectable suspension)
- Primary Outcome Measures
Name Time Method Total Opioid Burden Wound closure to time the discharge order is written or Day 30, whichever is sooner Total opioid consumed (IV and PO) postsurgically until 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 is written or Day 30, whichever is sooner. 1) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
Health Economic Benefit - Length of Stay Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner
- Secondary Outcome Measures
Name Time Method Readmission to Hospital Since Discharge Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate.
Make Unplanned VIsit(s) With Any Healthcare Providers Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. 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
Incidence of Opioid-related Adverse Events Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. 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.
Patient Satisfaction With Postsurgical Analgesia Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied.
Patient Discharged From the Hospital for at Least 3 Days Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. 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
Experienced Any Health Problems or Changed in Health Since Hospital Discharge Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. 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.
Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. 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.
Trial Locations
- Locations (3)
Florida Hospital d/b/a Colon & Rectal Surgery Center
🇺🇸Orlando, Florida, United States
University of Arizona College of Medicine
🇺🇸Tucson, Arizona, United States
University of South Florida
🇺🇸Tampa, Florida, United States