CompletedPhase 4

A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504

United States33 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 E…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Opioid Burden

Timeframe: Wound closure to time the discharge order is written or Day 30, whichever is sooner

Health Economic Benefits - Total Cost of Hospitalization

Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

Health Economic Benefit - Length of Stay

Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

Trial details

NCT IDNCT01509807

SponsorPacira Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2013-11-30

View on ClinicalTrials.gov More Retraction of Colostomy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Total Opioid Burden

Timeframe: Wound closure to time the discharge order is written or Day 30, whichever is sooner

Health Economic Benefits - Total Cost of Hospitalization

Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

Health Economic Benefit - Length of Stay

Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.