Urologic DiseasesPhase 3Baby ORIOLESNCT04826484

Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

A Phase 3 study testing Exparel 133 miligrams per 10 milliliter injection and Bupivacaine Hydrochloride in people with Urologic Diseases and Hypospadias, run by Johns Hopkins University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Urologic Diseases, Hypospadias, Undescended Testes
What is being tested?: Exparel 133 miligrams per 10 milliliter injection and Bupivacaine Hydrochloride
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2021to 26 Apr 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
Patients who are otherwise eligible to receive routine care following minor urologic surgery

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Hospital
Baltimore, Maryland, 21287

Other trials in United States

About this study

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

Conditions: Urologic Diseases, Hypospadias, Undescended Testes, Chordee, Hydrocele, Orchiectomy
Being tested: Exparel 133 miligrams per 10 milliliter injection, Bupivacaine Hydrochloride
Medical subject headings: Urologic Diseases, Hypospadias, Cryptorchidism, Testicular Hydrocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exparel 133 miligrams per 10 milliliter injectionDrug
Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine HydrochlorideDrug
Local wound infiltration with 0.25% bupivacaine.

Study groups in NCT04826484
Study group	Role	What they receive
Liposomal Bupivacaine plus 0.25% Bupivacaine	Experimental	Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine Receives: Drug: Exparel 133 miligrams per 10 milliliter injection; Drug: Bupivacaine Hydrochloride
0.25% Bupivacaine alone	Active comparator	Participants will receive local wound infiltration with 0.25% Bupivacaine alone. Receives: Drug: Bupivacaine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Who Are Opiate-free
Percentage of patients who are opiate-free at 48 hours postoperatively.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10-14 days postoperatively

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202126 Apr 2023

First posted1 Apr 2021
Study start1 Oct 2021
Primary completion26 Apr 2023
Study completion26 Apr 2023

Why it stopped: Met futility threshold at interim analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Urologic DiseasesStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04826484
Sponsor's protocol ID: IRB00284462
Acronym: Baby ORIOLES
Status last verified: Dec 2023
First submitted: 29 Mar 2021
Last updated: 26 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Gabrielson AT, Galansky L, Sholklapper T, Crigger C, Patel HD, Harris K, Haney N, Jing Y, Wang MH, Wu C, Gearhart JP, Di Carlo HN. Effectiveness of Liposomal Bupivacaine With Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Local Anesthetic for Children Undergoing Ambulatory Urologic Surgery: The Baby ORIOLES Randomized Clinical Trial. J Urol. 2024 Jan;211(1):37-47. doi: 10.1097/JU.0000000000003764. Epub 2023 Oct 23.
PubMed 37871332

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial Evaluating Use of Long-Acting Liposomal Bupivacaine (Exparel®) in Reducing Narcotic Pain Requirements in Pediatric Patients Undergoing Minor Urologic Procedures
ClinicalTrials.gov ID: NCT04826484
Acronym / sponsor ID: Baby ORIOLES / IRB00284462
Conditions: Urologic Diseases, Hypospadias, Undescended Testes, Chordee, Hydrocele, Orchiectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Met futility threshold at interim analysis
Enrolment: 104 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 1 Oct 2021 (actual)
Primary completion: 26 Apr 2023 (actual)
Study completion: 26 Apr 2023 (actual)
First posted: 1 Apr 2021 (actual)
Results: Posted 26 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Liposomal Bupivacaine plus 0.25% Bupivacaine	Experimental	Drug: Exparel 133 miligrams per 10 milliliter injection, Drug: Bupivacaine HydrochlorideParticipants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
0.25% Bupivacaine alone	Active comparator	Drug: Bupivacaine HydrochlorideParticipants will receive local wound infiltration with 0.25% Bupivacaine alone.

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
Patients who are otherwise eligible to receive routine care following minor urologic surgery

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exparel 133 miligrams per 10 milliliter injectionLocal wound infiltration with Exparel 133 miligrams per 10 milliliter injection	Drug	Liposomal Bupivacaine plus 0.25% Bupivacaine
Bupivacaine HydrochlorideLocal wound infiltration with 0.25% bupivacaine.	Drug	0.25% Bupivacaine alone, Liposomal Bupivacaine plus 0.25% Bupivacaine

Primary outcome

Percentage of Patients Who Are Opiate-free
Time frame: 48 hours postoperatively
Percentage of patients who are opiate-free at 48 hours postoperatively.
Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively
Time frame: 10-14 days postoperatively
Percentage of patients who are opiate-free at 10-14 days postoperatively.
Parents' Postoperative Pain Measure (PPPM) Scores
Time frame: 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.
Parents' Postoperative Pain Measure (PPPM) Scores
Time frame: 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.

3 secondary outcomes

Amount of Opioid Medication Used Post-discharge
Time frame: 10-14 days postoperatively
Percentage of Patients With Leftover Opioid Medication
Time frame: 10-14 days postoperatively
Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity
Time frame: 10-14 days postoperatively

Results and safety

Results posted to the registry on 26 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liposomal Bupivacaine Plus 0.25% Bupivacaine	52	50
0.25% Bupivacaine Alone	52	52

Primary outcome: Percentage of Patients Who Are Opiate-free

Time frame: 48 hours postoperatively. Number. Unit: percentage of patients opioid-free

Measure	Liposomal Bupivacaine Plus 0.25% Bupivacaine n = 52	0.25% Bupivacaine Alone n = 52
Value	60	62

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

Time frame: 10-14 days postoperatively. Number. Unit: percentage of pt opioid-free at 10-14d

Measure	Liposomal Bupivacaine Plus 0.25% Bupivacaine n = 50	0.25% Bupivacaine Alone n = 52
Value	60	62

Population analysed: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)

Primary outcome: Parents' Postoperative Pain Measure (PPPM) Scores

Time frame: 48 hours postoperatively. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Liposomal Bupivacaine Plus 0.25% Bupivacaine n = 52	0.25% Bupivacaine Alone n = 52
Value	2 (1 to 3)	2.5 (2 to 4)

Primary outcome: Parents' Postoperative Pain Measure (PPPM) Scores

Time frame: 10-14 days postoperatively. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Liposomal Bupivacaine Plus 0.25% Bupivacaine n = 50	0.25% Bupivacaine Alone n = 52
Value	0 (0 to 1)	0 (0 to 1)

Population analysed: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liposomal Bupivacaine Plus 0.25% Bupivacaine	0 of 52 (0%)	7 of 52 (13.5%)	0 of 52
0.25% Bupivacaine Alone	0 of 52 (0%)	5 of 52 (9.6%)	0 of 52

Limitations and caveats (from the sponsor): The trial met the predetermined threshold for early stopping. 1. Inability to blind surgeons due to differences in the appearance of the agents. 2. Unclear if the absorption profile of intervention is more rapid in groin/dorsal penile tissue compared to other areas. 3. Our cohort was enriched with low morbidity procedures which may have decreased differences between arms 4. Inability to compare the efficacy of the agents stratified by procedure type due to low enrollment in each procedure

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37871332Gabrielson AT, Galansky L, Sholklapper T, Crigger C, Patel HD, Harris K, Haney N, Jing Y, Wang MH, Wu C, Gearhart JP, Di Carlo HN. Effectiveness of Liposomal Bupivacaine With Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Local Anesthetic for Children Undergoing Ambulatory Urologic Surgery: The Baby ORIOLES Randomized Clinical Trial. J Urol. 2024 Jan;211(1):37-47. doi: 10.1097/JU.0000000000003764. Epub 2023 Oct 23.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heather N DiCarlo, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Who Are Opiate-free (time frame: 48 hours postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04826484, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.