Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

Phase 3TerminatedNCT04826484

Johns Hopkins University104 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

Urologic Diseases Hypospadias Undescended Testes Chordee Hydrocele Orchiectomy

Interventions

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.

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Percentage of Patients Who Are Opiate-free

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

Time frame: 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.

Time frame: 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.

Time frame: 48 hours postoperatively

Parents' Postoperative Pain Measure (PPPM) Scores

Time frame: 10-14 days postoperatively

Secondary Outcomes

Amount of Opioid Medication Used Post-discharge

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

Time frame: 10-14 days postoperatively

Percentage of Patients With Leftover Opioid Medication

Percentage of patients with leftover opioid medication

Time frame: 10-14 days postoperatively

Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity

Data from ClinicalTrials.gov

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