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Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

NCT ID: NCT04826484

Last Updated: 2023-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-04-26

Brief Summary

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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.

Detailed Description

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Conditions

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Urologic Diseases Hypospadias Undescended Testes Chordee Hydrocele Orchiectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Liposomal Bupivacaine plus 0.25% Bupivacaine

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

Group Type EXPERIMENTAL

Exparel 133 miligrams per 10 milliliter injection

Intervention Type DRUG

Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection

Bupivacaine Hydrochloride

Intervention Type DRUG

Local wound infiltration with 0.25% bupivacaine.

0.25% Bupivacaine alone

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

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

Local wound infiltration with 0.25% bupivacaine.

Interventions

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Exparel 133 miligrams per 10 milliliter injection

Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection

Intervention Type DRUG

Bupivacaine Hydrochloride

Local wound infiltration with 0.25% bupivacaine.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather N DiCarlo, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37871332 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB00284462

Identifier Type: -

Identifier Source: org_study_id