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4557
Defining the Cardiac Toxicity Risk of Liposomal Bupivacaine for postoperative analgesia during 5,001 major surgical procedures.
Session: MP-01b
Thurs, Nov. 16, 8:15-9:45 am
Saybrook Room

Please note, medically challenging cases are removed three months after the meeting and scientific abstracts after three years.

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Defining the Cardiac Toxicity Risk of Liposomal Bupivacaine for Postoperative Analgesia During 5,001 Major Surgical Procedures

Nisha Narula, MD, Vijaya Gottumukkala, MBBS, MD and Thomas A. Aloia, MD
University of Texas MD Anderson Cancer Center

Introduction

•Liposomal bupivacaine (LB) is an extended release formulation of the amide local anesthetic bupivacaine
•It typically provides effective pain relief for 48-72 hours
•The toxicity profile of the medication when used in expanded indications, including infiltration of minimally invasive and open incisions and with regional plane blocks, is not known
•To address this knowledge gap, this study details a comprehensive toxicity assessment in the largest clinical cohort receiving LB that has been reported

Methods

•Institutional IRB approved this study with waiver of consent
•Records of 5,001 consecutive patients who received liposomal bupivacaine (LB, Exparel®) for incisional pain control during major cancer operations from March 2016 to March 2017 were retrospectively reviewed
•In the majority of cases LB was used for regional plane blocks (Transversalis Abdominus Plane block/Posterior Intercostal Plane blocks)
•The remainder were local wound infiltration (laparoscopy ports/axillary/groin/breast/soft tissue resections)
•The most recent preoperative and first postoperative electrocardiogram (ECG) were compared
•Findings of new-onset bradycardia, conduction abnormalities (left or right bundle branch blocks, intraventricular conduction delays, AV block, or prolonged PR, QRS, or QTc intervals), ventricular tachycardia, and ventricular arrhythmias were further analyzed
•Clinical cardiac events were defined as cardiac arrest, ventricular or wide complex tachycardia, bradycardia/syncope, premature ventricular contractions, or changes other than ST or T wave changes (including bundle branch blocks)
•Additionally, all inpatient mortalities or additional cardiopulmonary arrest without ECG findings were identified
•Lastly, the hospital adverse event reporting data was cross-referenced for a thorough evaluation of all potential LB-related events

Results

•Of 5,001 patients who received LB at surgery, 627 (12.5%) had an ECG in the 7-day postoperative period for clinical indications including incidental telemetry findings, symptomatic cardiac evaluation, or hemodynamic alterations
•Seventeen of the 627 evaluated patients (0.34 %) had a significant new ECG finding within 96 hours of LB administration, as well as a clinical cardiac event
•Upon in-depth review, only 1 case was potentially related to LB toxicity
•This patient developed intraoperative bradycardia and hypotension shortly after a multilevel posterior intercostal plane block using 18 ml of 266 mg/20 ml LB mixed with 20 ml of 5 mg/ml bupivacaine 0.5%
•The intraoperative plasma bupivacaine level was 0.9 mcg/ml. In the remaining 16 patients, ECG, laboratory and clinical findings were not consistent with amide local anesthetic toxicity
•Overall mortality analysis identified 13 patients (0.25%) who died during their postoperative hospitalization
•No mortality due to a primary cardiac etiology attributable to amide local anesthetic toxicity
•Further assessment for additional events identified 3 patients with cardiac arrest, none of which demonstrated findings of LB toxicity
•Lastly, query of the hospital adverse event reporting database discovered one patient with a history of seizures who received LB and then experienced a postoperative seizure requiring intubation and an overnight ICU stay, without cardiac event
•In summary, a total of 34 out of 5,001 (0.68%) patients who received LB were identified with a postoperative event
•None were attributable to direct amide local anesthetic toxicity

Conclusions

•Largest reported cohort of major surgical patients treated with LB
•Multiple cross references employed to determine clinical cardiac safety profile
•Of 5,001 patients, 17 possible cardiac events and 13 deaths
•None of these events attributable to direct amide local anesthetic cardiac toxicity
•Thus, there is no substantive risk of cardiac toxicity from extravascular use of LB in this single institution study

References

•Butterworth, John F. Models and mechanisms of local anesthetic cardiac toxicity, a review. Regional Anesthesia and Pain Medicine, Vol. 35, No. 2, March-April 2010.
•Cox, B., Durieurx, M. E., and Marcus, M. A. E. Toxicity of local anesthetics. Best Practice & Research Clinical Anesthesiology. Vol. 17, No. 1. pp 111-136, 2003.
•Ilfeld, Brian M., et. al. Safety and side effect profile of Liposomal Bupivacaine (Exparel) in peripheral nerve blocks. Regional Anesthesia and Pain Medicine, Vol. 40, No. 5, September-October 2015.
•Richard, Brigitte M., et. al. Safety evaluation of EXPAREL (DepoFoam bupivacaine) administered by repeated subcutaneous injection in rabbits and dogs: species comparison. Journal of drug delivery, Vol. 2011.
•Viscusi, Eugene R., Sinatra, Raymond, Onel, Erol, and Ramamoorthy, Sonia L. The safety of Liposomal Bupivacaine, a novel local analgesic formation. Clin J Pain, Vol. 30, No. 2, February 2014.
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