Safety and Pharmacokinetics of Levobupivacaine Following Fascia Iliaca Compartment Block in Elderly Patients

• Published in: Drugs & aging Vol. 36; no. 6; pp. 541 - 548
• Main Authors: Odor, Peter M., Cavalier, Alison G., Reynolds, Neal D., Ang, King S., Parrington, Simon J., Xu, Hua, Johnston, Atholl, Sage, Frederic J.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.06.2019; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Analgesics; Anesthesia; Anesthetics, Local - adverse effects; Anesthetics, Local - blood; Anesthetics, Local - therapeutic use; Clinical trials; Drug dosages; Fascia; Female; Femoral Fractures - drug therapy; Femoral Fractures - physiopathology; Fractures; Geriatrics/Gerontology; Glycoproteins; Hip joint; Humans; Internal Medicine; Joint surgery; Levobupivacaine - adverse effects; Levobupivacaine - blood; Levobupivacaine - therapeutic use; Male; Medicine; Medicine & Public Health; Middle Aged; Nerve Block - methods; Nervous system; Older people; Pain; Pain Management - methods; Patients; Pharmacokinetics; Pharmacology/Toxicology; Pharmacotherapy; Pilot Projects; Short Communication; Toxicity; Treatment Outcome; Ultrasonic imaging; United Kingdom > UK
• ISSN: 1170-229X; 1179-1969
• DOI: 10.1007/s40266-019-00652-1

Background Fascia iliaca compartment block (FICB) is an increasingly popular analgesic technique in elderly patients with hip fracture. Despite requiring large volumes of local anaesthetic, there are no plasma pharmacokinetic data on FICB in elderly patients. Objectives The objective of this study was to determine the pharmacokinetic profile of a levobupivacaine 75 mg (30 mL 0.25%) FICB dose in patients aged ≥ 80 years with fractured femur. Methods This was a single-arm descriptive pilot study. Twelve adults aged ≥ 80 years with hip fracture received FICB performed under ultrasound guidance. Venous blood was sampled at 10, 20, 30, 45, 60, 75, 90, 105, 120 and 240 min after injection. Total plasma levobupivacaine concentration was measured by mass spectrometry. The main outcome measures were pharmacokinetic parameters, including maximum observed plasma concentration ( C max ), time to reach C max ( t max ) and area under the plasma concentration–time curve. Results The median (interquartile range [IQR]) C max was 0.82 μg/mL (0.47–1.03). t max was 45 min (41:20–60:00). No evidence of toxicity was identified. Plasma levobupivacaine concentrations were below the threshold associated with toxicity in younger, healthy patients (2.6 μg/mL). No association was found between individual patient C max and α 1 -acid glycoprotein, weight or body mass index, although the study was not powered for these outcomes. Conclusions Absorption of levobupivacaine was slow and all patients had plasma concentrations below the toxic threshold. This pharmacokinetic analysis concludes that the technique appears to be well-tolerated and efficacious at reducing pain and is associated with systemic plasma concentrations unlikely to be associated with major adverse effects in elderly patients. Clinical Trial Registration ISRCTN27364035 (UK Clinical Trials Gateway).