A Randomized Trial Evaluating Use of Long-Acting Liposomal Bupivacaine (Exparel®) in Reducing Narcotic Pain Requirements in Pediatric Patients Undergoing Minor Urologic Procedures
Overview
- Phase
- Phase 3
- Intervention
- Exparel 133 miligrams per 10 milliliter injection
- Conditions
- Urologic Diseases
- Sponsor
- Johns Hopkins University
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Percentage of Patients Who Are Opiate-free
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Liposomal Bupivacaine plus 0.25% Bupivacaine
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Intervention: Exparel 133 miligrams per 10 milliliter injection
Liposomal Bupivacaine plus 0.25% Bupivacaine
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Intervention: Bupivacaine Hydrochloride
0.25% Bupivacaine alone
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Intervention: Bupivacaine Hydrochloride
Outcomes
Primary Outcomes
Percentage of Patients Who Are Opiate-free
Time Frame: 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
Time Frame: 10-14 days postoperatively
Percentage of patients who are opiate-free at 10-14 days postoperatively.
Parents' Postoperative Pain Measure (PPPM) Scores
Time Frame: 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 Outcomes
- Percentage of Patients With Leftover Opioid Medication(10-14 days postoperatively)
- Amount of Opioid Medication Used Post-discharge(10-14 days postoperatively)
- Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity(10-14 days postoperatively)