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  • Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery

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Regional Anesthesia and Acute Pain: Original Article
Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery
  1. Catherine Vandepitte, MD*,
  2. Max Kuroda, PhD, MPH†,
  3. Richard Witvrouw, MD*,
  4. Ludwig Anne, MD*,
  5. Johan Bellemans, MD, PhD*,
  6. Kristoff Corten, MD, PhD*,
  7. Pascal Vanelderen, MD, PhD*,‡,
  8. Dieter Mesotten, MD, PhD*,‡,
  9. Ine Leunen, MD*,
  10. Micheline Heylen§,
  11. Sam Van Boxstael, MD*,
  12. Monika Golebiewski, MD†,
  13. Marc Van de Velde, MD, PhD§,
  14. Nebojsa Nick Knezevic, MD, PhD† and
  15. Admir Hadzic, MD, PhD*,†,§
  1. *Department of Anesthesiology, Ziekenhuis Öost-Limburg, Genk, Belgium
  2. †North American Institute of Continuing Education (NAICE), New York, NY
  3. ‡Faculty of Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium
  4. §Catholic University of Leuven, Leuven, Belgium
  1. correspondence: Admir Hadzic, MD, PhD, Ziekenhuis Oost-Limburg (ZOL), NYSORA-Europe CREER Center, Schiepse Bos 6, 3600 Genk, Belgium (e-mail: admir{at}nysora.com).

Abstract

Background and Objectives We examined whether liposome bupivacaine (Exparel) given in the interscalene brachial plexus block lowers pain in the setting of multimodal postoperative pain management for major shoulder surgery.

Methods Fifty-two adult patients were randomized to receive either 5 mL of 0.25% bupivacaine HCl immediately followed by 10 mL of liposome bupivacaine 133 mg (n = 26) or 15 mL of 0.25% standard bupivacaine alone (n = 26) in interscalene brachial plexus block. The primary outcome (worst pain in the first postoperative week) was assessed by the Modified Brief Pain Inventory short form. Secondary outcomes were overall satisfaction with analgesia (OBAS), functionality of the surgical arm, sleep duration, time to first opioid (tramadol) request and opioid consumption (mEq), sensory-motor block characteristics, and the occurrence of adverse effects.

Results Worst pain was lower in patients given liposome bupivacaine added to standard bupivacaine than in patients given standard bupivacaine alone (generalized estimating equation [GEE] estimated marginal mean values, 3.6 ± 0.3 vs 5.3 ± 0.4 points on the Numeric Rating Scale, respectively, although the effect was modest, 1.6 ± 0.5; 95% confidence interval, 0.8–2.5). Total OBAS scores indicated greater satisfaction (GEE estimated marginal mean values, 1.8 ± 0.3 vs 3.3 ± 0.4 on total OBAS, respectively, with modest effect, difference, 1.4 ± 0.5; 95% confidence interval, 0.5–2.4). There were no differences in any of the other secondary outcomes.

Conclusions Liposome bupivacaine added to standard bupivacaine may lower pain and enhance patient's satisfaction in the first postoperative week even in the setting of multimodal analgesia for major shoulder surgery.

This study was registered with clinicaltrials.gov (NCT02554357) on July 11, 2015, by Principal Investigator Catherine Vandepitte, MD.

https://doi.org/10.1097/AAP.0000000000000560

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    Footnotes

    • The study was conducted with Ziekenhuis Öost-Limburg (ZOL) Ethics Committee and Belgian governmental agency (FAGG) approvals for investigational new drugs (EudraCT 2015-001559-55), and was registered with clinicaltrials.gov (NCT02554357) on July 11, 2015.

      Dr. Hadzic has consulted and advised for Philipps, GE, Sonosite, Codman & Shrutleff, Inc. (Johnson and Johnson), Cadence, Pacira, Baxter, and B. Braun Medical. His recent industry-sponsored research includes Baxter and Pacira Pharma. Dr. Hadzic receives royalty income from B. Braun Medical.

      Funding: This study was funded by Pacira Pharmaceuticals.

      The rest of the authors declare no conflict of interest.

      Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.rapm.org).