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 range6 Years

SexALL

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

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