MP18-09: Liposomal Bupivacaine plus Bupivacaine vs. Bupivacaine Alone in Pediatric Patients Undergoing Urologic Surgery: Preliminary Report from the Baby ORIOLES Trial
Introduction: Long-acting liposomal bupivacaine (Exparel) was approved for children >6 years old however it has not been evaluated in children undergoing urologic surgery. We report preliminary safety and efficacy data of Exparel plus bupivacaine vs. bupivacaine alone for incisional infiltration or penile block in pediatric patients undergoing ambulatory urologic surgery as part of a randomized trial. Methods: The study is an IRB-approved prospective, single-blinded trial randomizing patients 6-18 years old 1:1 to receive Exparel plus 0.25% bupivacaine (experimental) vs. 0.25% bupivacaine alone (control) during ambulatory urology procedures (NCT04826484). Patients received Tylenol and Ibuprofen prescriptions and a rescue prescription of 3-5 doses 0.1 mg/kg Oxycodone. Efficacy endpoints include percent requiring no opioids within 48hr and 10-14d, parents’ postoperative pain measure (PPPM) scores at 48hr and 10-14d, and oral morphine equivalents (OMEQ) per kg given through 10-14d. Results: A total of 52 patients (29 control, 23 experimental) have been enrolled. Demographic, procedural, efficacy, and safety data are summarized in Table 1. There was no difference in percentage of patients requiring no post-operative opioids through 48hr (57% vs 55%, p=0.92). There was no difference in mean FLACC score in PACU (0.9 vs 1.2, p=0.64), PPPM score at 48hr (2.5 vs. 3.5, p=0.09) or PPPM score at 10-14d (0.55 vs. 0.6, p=0.67). The experimental arm had significantly reduced OMEQ/kg at 10-14d (0.06 vs. 0.2, p=0.02). However, OMEQ/kg utilization was low and limited to the 48hr post-op period in both arms. There were no intraoperative complications and similar use of perioperative Ketorlac between arms. Roughly 10% of patients in both arms had an unplanned phone call or message to the office (all related to swelling). No patients had unplanned presentation to the emergency department. Conclusions: This prospective, single-blinded randomized trial is the first to evaluate Exparel in pediatric patients undergoing urologic surgery. We demonstrate that albeit safe, the addition of Exparel to 0.25% bupivacaine did not improve validated pain scores or opioid-free rate at 48 hours. Formal assessment of efficacy and safety pending trial accrual. SOURCE OF Funding: Internally funded
