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Original research
Population pharmacokinetic and safety analysis of ropivacaine used for erector spinae plane blocks
  1. Eric S Schwenk1,
  2. Edwin Lam2,
  3. Ahmed A Abulfathi3,4,
  4. Stephan Schmidt3,
  5. Anthony Gebhart3,
  6. Scott D Witzeling5,
  7. Dalmar Mohamod5,
  8. Rohan R Sarna5,
  9. Akshay B Roy5,
  10. Joy L Zhao1,
  11. Gagan Kaushal6,
  12. Ankit Rochani6,7,
  13. Jaime L Baratta1 and
  14. Eugene R Viscusi1
  1. 1 Anesthesiology and Perioperative Medicine, Thomas Jefferson University Sidney Kimmel Medical College, Philadelphia, Pennsylvania, USA
  2. 2 Clinical Pharmacokinetics Research Lab, National Institutes of Health, Bethesda, Maryland, USA
  3. 3 Pharmaceutics, University of Florida College of Medicine, Orlando, Florida, USA
  4. 4 Clinical Pharmacology and Therapeutics, University of Maiduguri, Maiduguri, Borno, Nigeria
  5. 5 Anesthesiology and Perioperative Medicine, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA
  6. 6 Pharmaceutical Science, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
  7. 7 Pharmaceutical Sciences, St John Fisher University Wegmans School of Pharmacy, Rochester, New York, USA
  1. Correspondence to Dr Eric S Schwenk, Anesthesiology and Perioperative Medicine, Thomas Jefferson University Sidney Kimmel Medical College, Philadelphia, Pennsylvania, USA; Eric.Schwenk{at}jefferson.edu

Abstract

Introduction Erector spinae plane blocks have become popular for thoracic surgery. Despite a theoretically favorable safety profile, intercostal spread occurs and systemic toxicity is possible. Pharmacokinetic data are needed to guide safe dosing.

Methods Fifteen patients undergoing thoracic surgery received continuous erector spinae plane blocks with ropivacaine 150 mg followed by subsequent boluses of 40 mg every 6 hours and infusion of 2 mg/hour. Arterial blood samples were obtained over 12 hours and analyzed using non-linear mixed effects modeling, which allowed for conducting simulations of clinically relevant dosing scenarios. The primary outcome was the Cmax of ropivacaine in erector spinae plane blocks.

Results The mean age was 66 years, mean weight was 77.5 kg, and mean ideal body weight was 60 kg. The mean Cmax was 2.5 ±1.1 mg/L, which occurred at a median time of 10 (7–47) min after initial injection. Five patients developed potentially toxic ropivacaine levels but did not experience neurological symptoms. Another patient reported transient neurological toxicity symptoms. Our data suggested that using a maximum ropivacaine dose of 2.5 mg/kg based on ideal body weight would have prevented all toxicity events. Simulation predicted that reducing the initial dose to 75 mg with the same subsequent intermittent bolus dosing would decrease the risk of toxic levels to <1%.

Conclusion Local anesthetic systemic toxicity can occur with erector spinae plane blocks and administration of large, fixed doses of ropivacaine should be avoided, especially in patients with low ideal body weights. Weight-based ropivacaine dosing could reduce toxicity risk.

Trial registration number NCT04807504; clinicaltrials.gov.

  • Anesthesia, Local
  • Acute Pain
  • Pharmacology
  • Nerve Block

Data availability statement

Data are available upon reasonable request. De-identified data will be shared upon reasonable request and with sufficient time.

https://doi.org/10.1136/rapm-2022-104252

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    Data availability statement

    Data are available upon reasonable request. De-identified data will be shared upon reasonable request and with sufficient time.

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    Footnotes

    • Twitter @ESchwenkMD

    • Contributors ESS helped design the study, enroll patients, collect data, analyze data, and write the manuscript. EL helped design the study, analyze data, and write the manuscript. AAA helped design the study, analyze data, and write the manuscript. SS helped design the study, analyze data, and write the manuscript. AG helped design the study, analyze data, and write the manuscript. SDW, DM, RRS, ABR, and JLZ helped enroll patients, collect data, and write the manuscript. GK helped analyze samples and write the manuscript. AR helped analyze samples and write the manuscript. JLB helped design the study, enroll patients, and write the manuscript. ERV helped with the study concept, helped design the study, and write the manuscript. ESS is the author responsible for all content and is the guarantor.

    • Competing interests Viscusi was consultant or received funding from Heron, Esteve, Innacoll, and Salix.All others have no conflicts of interest.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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