Background Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks.
Methods Data from 6 controlled (phases I-III) studies were compiled involving single-injection ankle, femoral nerve, and intercostal nerve blocks (2 each). Adverse events (AEs) were monitored for 1 to 30 days after study drug administration.
Results Of 575 subjects, 335 received liposome bupivacaine (2–310 mg), 33 received bupivacaine HCl (75–125 mg), and 207 received normal saline (placebo). Overall, 76% of subjects receiving liposome bupivacaine experienced 1 or more AEs compared with 61% receiving bupivacaine HCl and 76% receiving placebo. The most frequently reported AEs among subjects receiving liposome bupivacaine were nausea, pyrexia, pruritus, constipation, and vomiting. The most common treatment-related AE was hypesthesia among subjects treated with liposome bupivacaine or bupivacaine HCl. Incidence of nervous system AEs for liposome bupivacaine, bupivacaine HCl, and placebo was 21%, 27%, and 21%, respectively. Similarly, incidence of cardiac AEs was 9%, 0%, and 12%, respectively. At least 1 serious AE occurred in 8% of subjects receiving liposome bupivacaine compared with 10% of those receiving placebo (none assessed by investigators as related to study medication).
Conclusions Liposome bupivacaine has a similar safety and side effect profile to bupivacaine HCl and normal saline, suggesting that most of the more common AEs are related to either opioid rescue or the surgical procedure itself.
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Work should be attributed the all authors’ institutions.
B.M.I. was involved with study design, execution, and data collection; analysis/interpretation of data and manuscript drafting/revising, review, and final approval. E.R.V. was involved with the analysis/interpretation of data, drafting/revising of the manuscript, review, and final approval. A.H. was involved with contribution of vital reagents/tools/patents, acquisition of data, statistical analysis, and study supervision or coordination, manuscript review, and final approval. H.S.M. was involved in the analysis or interpretation of data, drafting/revising the manuscript for content including medical writing, had access to all data used in this study, gave final approval of the version to be published, and takes overall responsibility for the data and the accuracy of the manuscript. M.D.M. was involved in literature searching, writing, and editorial revisions based on coauthor feedback throughout the manuscript preparation process and final approval. J.L. was involved with the acquisition of data, statistical analysis and interpretation of data, along with the drafting/revising of the manuscript, review, and final approval. G.P.J. was involved with the analysis/interpretation of data, drafting/revising of the manuscript, review, and final approval. The authors are fully responsible for the content, editorial decisions, and opinions expressed in the current article.
The studies included within this manuscript were funded by Pacira Pharmaceuticals, Inc, which contributed to the studies’ design, statistical analysis, manuscript preparation, and subject recruitment costs. Editorial assistance was provided by Peloton Advantage, LLC, supported by Pacira Pharmaceuticals, Inc. The authors did not receive an honorarium related to the development of this manuscript.
This study was presented, in part, as an abstract at The American Society of Anesthesiologists Annual Meeting, October 13, 2014, New Orleans, LA.
For 2 of the studies contributing data to the current manuscript, Pacira Pharmaceuticals, Inc, provided B.M.I.’s institution with research funding. For 1 of these 2, he acted in a consulting role for Pacira Pharmaceuticals, Inc (during protocol and manuscript authorship periods), and received research funding from Pacira Pharmaceuticals, Inc, for that investigation, including funding for his nonclinical time allowing work on the project during subject enrollment. B.M.I. has received honoraria from Pacira Pharmaceuticals, Inc., as a speaker and workshop director. E.R.V. has received research funding for his institution from Pacira Pharmaceuticals, Inc, AcelRx Pharmaceuticals, Inc, and Cumberland Pharmaceuticals. He has been a consultant and speaker for AcelRx Pharmaceuticals, Inc, Mallinckrodt Pharmaceuticals, Cadence Pharmaceuticals, Cubist Pharmaceuticals, Inc, Salix Pharmaceuticals, Inc, Trevena Inc, and Pacira Pharmaceuticals, Inc. A.H. has consulted and advised for SkyePharma, GE, SonoSite, Codman & Shurtleff, Inc (Johnson & Johnson Health Care Systems, Inc), Cadence Pharmaceuticals, Inc, Pacira Pharmaceuticals, Inc, Baxter, and B. Braun Medical Inc. He has also received research funding from GlaxoSmithKline, Pacira Pharmaceuticals, Inc, and Baxter. He receives royalty income from B. Braun Medical Inc. H.S.M. has been a consultant for Pacira Pharmaceuticals, Inc. He has also received clinical research funding from Pacira Pharmaceuticals, Inc, Innocoll Pharmaceuticals, DURECT Corporation, and Research Concepts, Inc. M.D.M. provided editorial and writing assistance supported by Pacira Pharmaceuticals, Inc. J.L. is a consultant for Pacira Pharmaceuticals, Inc. G.P.J. Joshi has received honoraria from Pacira Pharmaceuticals, Inc, as a consultant/lecturer/speakers’ bureau member.
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