NCT04826484: Baby ORIOLES

Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

Terminated Phase 3 Results posted Last updated 26 December 2023

What this trial tests

Phase 3 trial testing Exparel 133 miligrams per 10 milliliter injection in Urologic Diseases in 104 participants. Terminated before completion.

Timeline

1 October 2021

Primary endpoint
26 April 2023

26 April 2023

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	104
Start date	1 October 2021
Primary completion	26 April 2023
Estimated completion	26 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Exparel 133 miligrams per 10 milliliter injection
• Bupivacaine Hydrochloride (Bupivacaine Hydrochloride) — full drug profile →

Conditions studied

• Urologic Diseases — all drugs for Urologic Diseases →
• Hypospadias — all drugs for Hypospadias →
• Undescended Testes — all drugs for Undescended Testes →
• Chordee — all drugs for Chordee →

Sponsor

Johns Hopkins University

Who can join

6 and older, any sex, with Urologic Diseases or Hypospadias. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients Who Are Opiate-free Primary · 48 hours postoperatively

Percentage of patients who are opiate-free at 48 hours postoperatively.

Group	Value	95% CI
Liposomal Bupivacaine Plus 0.25% Bupivacaine	60
0.25% Bupivacaine Alone	62

Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively Primary · 10-14 days postoperatively

Percentage of patients who are opiate-free at 10-14 days postoperatively.

Group	Value	95% CI
Liposomal Bupivacaine Plus 0.25% Bupivacaine	60
0.25% Bupivacaine Alone	62

Parents' Postoperative Pain Measure (PPPM) Scores Primary · 48 hours postoperatively

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.

Group	Value	95% CI
Liposomal Bupivacaine Plus 0.25% Bupivacaine	2	1 – 3
0.25% Bupivacaine Alone	2.5	2 – 4

Parents' Postoperative Pain Measure (PPPM) Scores Primary · 10-14 days postoperatively

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.

Group	Value	95% CI
Liposomal Bupivacaine Plus 0.25% Bupivacaine	0	0 – 1
0.25% Bupivacaine Alone	0	0 – 1

Amount of Opioid Medication Used Post-discharge Secondary · 10-14 days postoperatively

Weight based amount of opioid medication (in OMEQ/kg) used post-discharge.

Group	Value	95% CI
Liposomal Bupivacaine Plus 0.25% Bupivacaine	0	0 – 0.1
0.25% Bupivacaine Alone	0	0 – 0.22

Percentage of Patients With Leftover Opioid Medication Secondary · 10-14 days postoperatively

Percentage of patients with leftover opioid medication

Group	Value	95% CI
Liposomal Bupivacaine Plus 0.25% Bupivacaine	14
0.25% Bupivacaine Alone	24

Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity Secondary · 10-14 days postoperatively

Cumulative incidence of complications related to local anesthetic systemic toxicity

Group	Value	95% CI
Liposomal Bupivacaine Plus 0.25% Bupivacaine	0
0.25% Bupivacaine Alone	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liposomal Bupivacaine Plus 0.25% Bupivacaine

Serious: 0/52 (0%)

Deaths: 0/52

0.25% Bupivacaine Alone

Serious: 0/52 (0%)

Deaths: 0/52

Other adverse events (2 terms — click to expand)

Reaction	System	Liposomal Bupivacaine Plus…	0.25% Bupivacaine Alone
Postoperative swelling	Renal and urinary disorders	—	—
Penile Hematoma	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT04826484 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.