A Single Center Experience Using Liposomal Bupivacaine in Pediatric Patients Having Non-Cardiac Surgery

By Logan D. Glosser, BA, Michael Walters, MD, Barak Cohen, MD, MHA, Nadav Schacham, MD, Sanchit Ahuja, MD, Eva Rivas Ferreira, MD, PhD, Remie Saab, MD, Surendrasingh Chhabada, MD, Alparslan Turan, MD
Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, OH, USA
(Summarized and submitted by Logan Glosser, BA, and Remie Saab, MD)

Postoperative pain control in the pediatric population remains challenging. Infiltration of the surgical wound with local anesthetics at the conclusion of surgery is a common component of the analgesic treatment. This infiltration was limited to the available short acting local anesthetics. In adults, the FDA has approved the use of liposomal bupivacaine (Exparel, injectable suspension, Pacira Pharmaceuticals Inc., Parsippany, NJ, USA), allowing a slow release and providing longer pain relief. We here describe a single-center experience of off-label surgical wound infiltration with liposomal bupivacaine in pediatric surgical patients.

We conducted a retrospective cohort analysis to describe the incidence of serious adverse events potentially related to local anesthetic toxicity in patients 0 to 16 years of age who received wound infiltration with either liposomal or plain bupivacaine during non-cardiac surgery between 2013 and 2017 in the Cleveland Clinic. Eligible patients in the two groups were matched by age, ASA status, and type of procedure. Patient records were evaluated by two investigators blinded to the type of local anesthetic to identify any of 13 predefined signs and symptoms potentially related to local anesthetic systemic toxicity (LAST) and six other major complications during the initial 48 postoperative hours. The primary outcome was the incidence of LAST defined as the presence of two or more of the pre-defined complications possibly related to anesthetic toxicity. We also conducted a sensitivity analysis to compare the incidence of a single sign or symptom possibly related to anesthetic toxicity.

356 patients who received liposomal bupivacaine were matched with 568 patients who received plain bupivacaine. The median [interquartile range] dose of liposomal bupivacaine was 266 [133, 266] mg. Of note, even after matching, nearly 40% of patients in the liposomal bupivacaine group underwent extensive spinal fusion surgery (compared to only 3% in the control group), which led to residual imbalance between the two groups. The primary outcome did not occur in any patient (P>0.99). A pre-planned sensitivity analysis identified five cases having a single sign/symptom possibly related to LAST (three in the liposomal group and two in the plain bupivacaine group, relative risk 2.4, 95% CI 0.4-14.0, P=0.38).

In our cohort of more than 900 pediatric surgical patients, with more than 350 receiving liposomal bupivacaine, we could not identify a single case of LAST, and the incidence of even isolated symptoms potentially related to local anesthetic toxicity was very low.