Detailed by Andrew Gabrielson, MD, PGY-4, at the AUA Annual Meeting 2023.
In this study, we report the results of an internally funded phase three single blinded factorial design trial, randomizing patients 1 to 1 to receive XL or liposomal BCA plus quarter percent PICCA versus quarter percent alone. And this was during ambulatory pediatric urology procedures. Patients were cross randomized uh on procedure type to two regional block techniques. All of them were discharged home with Tylenol and Motrin and then each was given a rescue opioid prescription only as needed. Our study was powered to the primary end point which was the proportion of patients requiring no opioids through 48 hours. Postoperatively. We had 100 and two patients in total 51 in each arm that were enrolled with no differences in patient demographics or per procedural characteristics. For our primary end point, we found no difference in the 48 hour opioid free rate between groups at 61% in both arms. The experimental arm had improved parents postoperative pain metrics at 48 hours, but there was no difference in opioid utilization or numerical pain scores. At either time point, the medication was safe, no major anesthetic or procedural complications were observed. So, in summary, This prospective randomized trial is the first to evaluate liposomal be pivo or XL in pediatric patients undergoing ambulatory neurologic surgery. At our interim analysis, the study met its futility threshold and was stopped and we provide strong evidence that albeit safe with mild short term improvements in validated pain metrics. The addition of XL to quarter percent eivin did not significantly reduce opioid utilization or improve opioid free rate at 48 hours postoperatively. The reason that we performed this study was to look at whether or not this medication would be, you know, really a game changer in terms of improving pain scores after these types of procedures, most of them are outpatient, most of them can be done without the use of opioid medication. Um And we simply included that as a rescue in case this regimen was not effective. Um I think that this is helpful and even though it was a negative trial, it tells us that uh this medication which is quite, quite expensive is, is no better than the $5 medication that we currently use as standard of care.
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