Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

Urologic Diseases Clinical Trial

— Baby ORIOLES  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04826484
• Other study ID #: IRB00284462
• Status: Terminated
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: April 26, 2023

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: April 26, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chordee
• Cryptorchidism
• Hydrocele
• Hypospadias
• Orchiectomy
• Undescended Testes
• Urologic Diseases

Intervention

Drug:
• Exparel 133 miligrams per 10 milliliter injection
Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
• Bupivacaine Hydrochloride
Local wound infiltration with 0.25% bupivacaine.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Are Opiate-free	Percentage of patients who are opiate-free at 48 hours postoperatively.	48 hours postoperatively
Primary	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
Primary	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
Primary	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	Amount of Opioid Medication Used Post-discharge	Weight based amount of opioid medication (in OMEQ/kg) used post-discharge.	10-14 days postoperatively
Secondary	Percentage of Patients With Leftover Opioid Medication	Percentage of patients with leftover opioid medication	10-14 days postoperatively
Secondary	Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity	Cumulative incidence of complications related to local anesthetic systemic toxicity	10-14 days postoperatively