← Back to Search

Local Anesthetic

Liposomal Bupivacaine plus 0.25% Bupivacaine for Urological Diseases (Baby ORIOLES Trial)

Phase 3

Waitlist Available

Led By Heather N DiCarlo, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-14 days postoperatively

Awards & highlights

Baby ORIOLES Trial Summary

This trial will test whether a long-acting painkiller can reduce pain and the need for narcotics in children after minor urology procedures.

Eligible Conditions

Urological Diseases
Orchiectomy
Hydrocele
Hypospadias
Cryptorchidism
Chordee

Baby ORIOLES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10-14 days postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10-14 days postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-14 days postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parents' Postoperative Pain Measure (PPPM) Scores

Percentage of Patients Who Are Opiate-free

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

Secondary outcome measures

Amount of Opioid Medication Used Post-discharge

Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity

Percentage of Patients With Leftover Opioid Medication

Baby ORIOLES Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Liposomal Bupivacaine plus 0.25% BupivacaineExperimental Treatment2 Interventions

Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine

Group II: 0.25% Bupivacaine aloneActive Control1 Intervention

Participants will receive local wound infiltration with 0.25% Bupivacaine alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,259 Previous Clinical Trials

14,820,549 Total Patients Enrolled

Heather N DiCarlo, MDPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more openings for participants in this research study?

"The clinical trial is still open for recruitment, as indicated by the information on clinicaltrials.gov. It was first published on October 1st 2021 and last modified on October 13th 2022."

Answered by AI

How many volunteers are engaged in this clinical experiment?

"Affirmative. Information hosted by clinicaltrials.gov suggests that this medical trial, first posted on October 1st 2021, is actively recruiting patients. The target number of participants for the study is 200 at a single site."

Answered by AI

What clinical indications is Exparel 133 MG Per 10 ML Injection typically prescribed for?

"Exparel 133 MG Per 10 ML Injection is a medication most commonly used to treat permphigus. Other clinical applications include the management of acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

What have been the reported adverse effects of Exparel 133 MG Per 10 ML Injection?

"Exparel 133 MG Per 10 ML Injection has been granted approval, thus receiving a rating of 3 on the safety scale."

Answered by AI

Could you provide details on prior research done with Exparel 133 MG Per 10 ML Injection?

"At the present moment, there are 109 clinical trials examining Exparel 133 MG Per 10 ML Injection with 18 of those trials in their final stage. Philadelphia is one of many areas hosting these studies and 144 total locations have been identified as research sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

2021. "Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04826484.