TerminatedPhase 3

Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

Stopped: Met futility threshold at interim analysis

United States104 participantsStarted 2021-10-01

Plain-language summary

This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.

Who can participate

Age range

6 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: * Pediatric patients 6 years and older undergoing minor pediatric urologic surgery * Patients who are otherwise eligible to receive routine care following minor urologic surgery Exclusion Criteria: * Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal, hepatic dysfunction) * Pediatric patients younger than 6 years of age * Pediatric patients with a history of pain syndromes or are unable to tolerate opiate medication * Unwilling to participate in 48 hours and 10-14 day follow-up phone calls

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

Percentage of Patients Who Are Opiate-free

Timeframe: 48 hours postoperatively

Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively

Timeframe: 10-14 days postoperatively

Parents' Postoperative Pain Measure (PPPM) Scores

Timeframe: 48 hours postoperatively

Parents' Postoperative Pain Measure (PPPM) Scores

Timeframe: 10-14 days postoperatively

Trial details

NCT IDNCT04826484

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-26

Results submitted2023-12-06

View on ClinicalTrials.gov More Urologic Diseases trials

Who can participate

Age range

6 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

Percentage of Patients Who Are Opiate-free

Timeframe: 48 hours postoperatively

Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively

Timeframe: 10-14 days postoperatively

Parents' Postoperative Pain Measure (PPPM) Scores

Timeframe: 48 hours postoperatively

Parents' Postoperative Pain Measure (PPPM) Scores

Timeframe: 10-14 days postoperatively