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

A Randomized Trial Evaluating Use of Long-Acting Liposomal Bupivacaine (Exparel®) in Reducing Narcotic Pain Requirements in Pediatric Patients Undergoing Minor Urologic Procedures

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.

Study Overview

• Status: Terminated
• Conditions: Urologic Diseases; Hypospadias; Hydrocele; Undescended Testes; Orchiectomy; Chordee
• Intervention / Treatment: Drug: Exparel 133 miligrams per 10 milliliter injection; Drug: Bupivacaine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Andrew T Gabrielson, MD; Phone Number: 4109550833; Email: agabrie7@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal Bupivacaine plus 0.25% Bupivacaine; Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine	Drug: Exparel 133 miligrams per 10 milliliter injection; Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection; Drug: Bupivacaine Hydrochloride; Local wound infiltration with 0.25% bupivacaine.
Active Comparator: 0.25% Bupivacaine alone; Participants will receive local wound infiltration with 0.25% Bupivacaine alone.	Drug: Bupivacaine Hydrochloride; Local wound infiltration with 0.25% bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Are Opiate-free	Percentage of patients who are opiate-free at 48 hours postoperatively.	48 hours postoperatively
Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively	Percentage of patients who are opiate-free at 10-14 days postoperatively.	10-14 days postoperatively
Parents' Postoperative Pain Measure (PPPM) Scores	15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain.	48 hours postoperatively
Parents' Postoperative Pain Measure (PPPM) Scores	15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain.	10-14 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Opioid Medication Used Post-discharge	Weight based amount of opioid medication (in OMEQ/kg) used post-discharge.	10-14 days postoperatively
Percentage of Patients With Leftover Opioid Medication	Percentage of patients with leftover opioid medication	10-14 days postoperatively
Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity	Cumulative incidence of complications related to local anesthetic systemic toxicity	10-14 days postoperatively

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Heather N DiCarlo, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Urogenital Abnormalities; Congenital Abnormalities; Testicular Diseases; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias; Urologic Diseases; Cryptorchidism; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB00284462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes