Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

Phase 3

Terminated

• Conditions: Urologic Diseases; Chordee; Hypospadias; Hydrocele; Orchiectomy; Undescended Testes
• Interventions: Drug: Exparel 133 miligrams per 10 milliliter injection; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04826484
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-10-01
• Primary Completion: 2023-04-26
• Study Completion: 2023-04-26
• Status Verified: 2023-12
• Results First Submitted: 2023-12-06
• Results First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Results First Posted: 2023-12-26
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine plus 0.25% Bupivacaine	Exparel 133 miligrams per 10 milliliter injection	Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
0.25% Bupivacaine alone	Bupivacaine Hydrochloride	Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Liposomal Bupivacaine plus 0.25% Bupivacaine	Bupivacaine Hydrochloride	Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Are Opiate-free	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	10-14 days postoperatively	Percentage of patients who are opiate-free at 10-14 days postoperatively.
Parents' Postoperative Pain Measure (PPPM) Scores	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States