Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

NCT04826484 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: IRB00284462
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Amount of Opioid Medication Used Post-discharge

  10-14 days postoperatively

• Percentage of Patients With Leftover Opioid Medication

  10-14 days postoperatively

• Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity

  10-14 days postoperatively

Study Arms (2)

Liposomal Bupivacaine plus 0.25% Bupivacaine

EXPERIMENTAL

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

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.

Drug: Bupivacaine Hydrochloride

Interventions

Exparel 133 miligrams per 10 milliliter injection DRUG

Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection

Liposomal Bupivacaine plus 0.25% Bupivacaine

Bupivacaine Hydrochloride DRUG

Local wound infiltration with 0.25% bupivacaine.

0.25% Bupivacaine alone; Liposomal Bupivacaine plus 0.25% Bupivacaine

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 37871332 DERIVED

MeSH Terms

Conditions

Urologic Diseases; Hypospadias; Cryptorchidism; Testicular Hydrocele

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Penile Diseases; Genital Diseases, Male; Genital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Testicular Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

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

Results Point of Contact

• Title: Andrew T. Gabrielson, MD
• Organization: Johns Hopkins University School of Medicine

atg@jhmi.edu

410-955-5000

Study Officials

• Heather N DiCarlo, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: October 1, 2021
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)