A Phase I Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Liposomal Bupivacaine for Sciatic Nerve Block in the Popliteal Fossa for Bunionectomy

Authors

• Daniel I Sessler
• Xiaodong Bao
• David Leiman
• Jia Song
• Jason Chittenden
• Alexander Voelkner
• Alparslan Turan
• Jeffrey Gadsden

Language

English

Publication Date

4-1-2025

Journal

The Journal of Clinical Pharmacology

DOI

10.1002/jcph.6159

PMID

39520051

PMCID

PMC11937984

PubMedCentral® Posted Date

11-8-2024

PubMedCentral® Full Text Version

Post-print

Abstract

This trial assessed the pharmacokinetics, pharmacodynamics, and safety of liposomal bupivacaine given via ultrasound-guided popliteal sciatic nerve block with or without immediate-release bupivacaine hydrochloride in adults having bunionectomies. Forty-five adults were enrolled into four sequential cohorts: (1) liposomal bupivacaine 266 mg with bupivacaine hydrochloride 50 mg; (2) liposomal bupivacaine 133 mg with bupivacaine hydrochloride 50 mg; (3) liposomal bupivacaine 266 mg; or (4) bupivacaine hydrochloride 100 mg. Outcomes included pharmacokinetics (e.g., bupivacaine maximum plasma concentration [C

Keywords

Humans, Bupivacaine, Nerve Block, Male, Sciatic Nerve, Anesthetics, Local, Middle Aged, Female, Liposomes, Adult, Hallux Valgus, Aged, Young Adult, anesthesia, foot and ankle surgery, immediate‐release bupivacaine, liposomes, postoperative pain, ultrasound‐guided nerve block

Published Open-Access

yes

Recommended Citation

Sessler, Daniel I; Bao, Xiaodong; Leiman, David; et al., "A Phase I Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Liposomal Bupivacaine for Sciatic Nerve Block in the Popliteal Fossa for Bunionectomy" (2025). Faculty, Staff and Student Publications. 1544.
https://digitalcommons.library.tmc.edu/uthsph_docs/1544