Safety and Efficacy of Long-Acting Liposomal Bupivacaine in Pediatric Patients Undergoing Ambulatory Urologic Surgery: Preliminary Report from the Baby ORIOLES Trial
Andrew Gabrielson, MD, Tamir Sholklapper, MD, Chad Crigger, MD, Logan Galansky, MD, Nora Haney, MD, MBA, Kelly Harris, MD, Charlotte Wu, MD, John Gearhart, MD, Heather Di Carlo, MD.
Johns Hopkins Hospital, Baltimore, MD, USA.
BACKGROUND: Despite increased cognizance of the opioid epidemic, overprescribing of opioid medication in children (particularly those greater than 10 years old) undergoing ambulatory urologic surgery remains high. An important means of mitigating opioid requirement in the peri- and postoperative period is the use of local anesthetics at the time of surgery. Long-acting liposomal bupivacaine (Exparel®) was recently approved by the FDA for use in children 6 years and older for perioperative analgesia however there are few reports of its use in children undergoing urologic surgery. We report preliminary safety and efficacy data of long-acting liposomal bupivacaine plus bupivacaine hydrochloride for neuraxial blockade in pediatric patients undergoing ambulatory urologic surgery as part of an ongoing randomized trial.
METHODS: The study is an IRB-approved prospective, single-blinded, and randomizes patients in 1:1 fashion to receive Exparel® plus 0.25% bupivacaine (experimental arm) versus 0.25% bupivacaine alone (control) during ambulatory pediatric urology procedures. Patients are sub-stratified based on route of administration: penile block (circumcision, hypospadias repair, penile cyst excision, chordeolysis) or local wound infiltration (orchiopexy, orchiectomy, inguinal hernia, hydrocelectomy, varicocelectomy). Patients 6 years and older, with no history of pain syndromes or contraindications to receiving local anesthetics were enrolled. The efficacy endpoints include: percent requiring no post-op opioids at 48 hours and at 10-14 days, parents' postoperative pain measure (PPPM) scores at 48 hours and 10-14 days postoperatively, amount of opioid used following discharge, and the amount of opioid leftover at 10-14 days. The safety endpoint include is incidence of pre-defined complications related to local anesthetic systemic toxicity. T-test and Fisher's exact test were used where appropriate.
RESULTS: A total of 14 consecutive patients (8 control arm, 6 experimental arm) were enrolled with complete follow-up data. Patient demographics, procedure information, efficacy data and safety data are summarized in Table 1. Both arms of the study were well-tolerated with no intraoperative surgical or anesthetic complications. No patient in either group required an unplanned phone call to the urology office or presentation to the emergency department. There was no significant difference in percentage of patients requiring no post-operative opioids at 48 hours (5/6 vs. 4/8, p=0.31). Additionally, there was no significant difference in PPPM pain scores at 48 hours (4.5 vs. 4, p=0.28) or 10-14 days postoperatively (0 vs. 0.5, p=0.47) between the two arms. Patients in the experimental arm had significantly improved FLACC pain scores on day of discharge and reduced OMEQ at 48 hours. However, FLACC scores were tolerable in both arms and OMEQ utilization was low and limited to the 48-hour post-op period.
CONCLUSIONS: Long-acting liposomal bupivacaine plus 0.25% bupivacaine is safe in pediatric patients undergoing ambulatory urologic surgery. The addition of long-acting liposomal bupivacaine may reduce opioid requirements and improve immediate post-operative pain however it did not impact pain scores at 48 hours or 10-14 days postoperatively. 
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