Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel (Baby ORIOLES)

Johns Hopkins University

Status and phase: Terminated; Phase 3

Conditions: Orchiectomy; Hydrocele; Undescended Testes; Hypospadias; Chordee; Urologic Diseases

Treatments: Drug: Bupivacaine Hydrochloride; Drug: Exparel 133 miligrams per 10 milliliter injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04826484

IRB00284462

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Liposomal Bupivacaine plus 0.25% Bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride

Drug: Exparel 133 miligrams per 10 milliliter injection

0.25% Bupivacaine alone

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride