Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

Study Overview
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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.

Official Title
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A Randomized Trial Evaluating Use of Long-Acting Liposomal Bupivacaine (Exparel®) in Reducing Narcotic Pain Requirements in Pediatric Patients Undergoing Minor Urologic Procedures

Conditions
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Urologic Diseases, Hypospadias, Undescended Testes, Chordee, Hydrocele, Orchiectomy

Intervention / Treatment
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* Drug: Exparel 133 miligrams per 10 milliliter injection
* Drug: Bupivacaine Hydrochloride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine plus 0.25% Bupivacaine<br>Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine | Drug: Exparel 133 miligrams per 10 milliliter injection<br>* Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection<br>Drug: Bupivacaine Hydrochloride<br>* Local wound infiltration with 0.25% bupivacaine.<br>|
| Active Comparator: 0.25% Bupivacaine alone<br>Participants will receive local wound infiltration with 0.25% Bupivacaine alone. | Drug: Bupivacaine Hydrochloride<br>* Local wound infiltration with 0.25% bupivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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