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

Abstract

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 is no safety data on plasma concentration of local anaesthetic after FICB in elderly patients. Objectives: The aim was to determine the safety and pharmacokinetic profile of a 75 mg levobupivacaine (30ml 0.25%) FICB dose in patients aged ≥80 years with a fractured neck of femur. Methods: This was a single-arm descriptive study. 12 adults, aged ≥80 years and admitted to hospital 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 minutes after injection. Total plasma levobupivacaine concentration was measured by mass spectrometry method. Main outcome measures were pharmacokinetic parameters, including maximum observed plasma concentration (Cmax), time to reach Cmax (tmax) and area under the plasma concentration-time curve (AUC). Results: Median (IQR) Cmax was 0.82 μg.ml-1 (0.47-1.03). tmax was 45 minutes (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-1). No association was found between individual patient Cmax and α1 acid glycoprotein, weight, or body mass index. Conclusions: Absorption of levobupivacaine was slow and all patients had plasma concentrations below the toxic threshold. This pharmacokinetic analysis supports the safety and efficacy of FICB in elderly patients with hip fracture. Clinical trial registration: ISRCTN27364035 (UK Clinical Trials Gateway) 3 Key points  Use of fascia iliaca compartment block in elderly patients is safe, well tolerated and effective in reducing pain associated with a fractured neck of femur.  Following administration of a 75mg dose of levobupivacaine via a fascia iliaca compartment block, systemic absorption of local anaesthetic into the plasma is slow (tmax 45 minutes).  No relationship was observed between Cmax and α1 acid glycoprotein, weight, or body mass index.

Pharmacokinetic Profile of Plasma Levobupivacaine Following Fascia Iliaca Compartment Block for Proximal Femoral Fracture in Older Patient

“…As demonstrated by the product ion spectra for bupivacaine and the deuterated internal control D9-bupivacaine (Figure 1), although lo- cal anesthetics can be very close in size and chemistry, they can be distinguished from one another by chromatography [6]. The data in this study are in general agreement with the gas chromatography-mass spectrometry data described by Odor et al [7]. Although LC-MS/MS is an accurate analytical method, it cannot be used for real-time detection of toxic plasma levels of levobupivacaine, as blood sample preparation and running of the LC-MS/MS method takes over 8 hours.…”

“…The data from this study have added to the pharmacokinetic profile of plasma levobupivacaine of older patients following FICB for hip fracture surgery. This local anesthetic technique was demonstrated to be safe for use in older patients supporting previous results [7]. The data collected can be used to help local anesthetic dosing in older patients and improve local anesthetic safety.…”

Ultrasound-Guided Preoperative Fascia Iliaca Compartment Block for Pain Relief During Positioning for Spinal Anesthesia in Patients With Hip Fracture

“…Visual analogue scores (VAS) were calculated during positioning for spinal anesthesia, and it was concluded that VAS scores were lower in patients who received FICB. In a similar study, Odor et al studied the pharmacokinetic profile of levobupivacaine for fascia iliaca block in patients above 80 years [9]. They used 30 ml of 0.25% levobupivacaine.…”

A Randomized Comparison of Plasma Levobupivacaine Concentrations Following Thoracic Epidural Analgesia and Subpleural Paravertebral Analgesia in Open Thoracic Surgery

“…They found C max similar in both groups with means of approximately 1 mg × L −1 and faster absorption from the transversus abdominis plane. One study investigated the pharmacokinetics of levobupivacaine after a single bolus of the drug to the fascia iliaca compartment in elderly frail patients with a fractured neck of the femur [21]. The authors reported the highest C max as 1.42 mg × L −1 and that none of their patients exhibited any symptoms of local anesthetic systemic toxicity (LAST).…”