Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients

Last updated: April 29, 2025
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Anesthesia

Treatment

Pharmacokinetic study of intravenous lidocaine

biological blood test

Pain

Clinical Study ID

NCT06795100
35RC23_9774_07_ElderLIDO_1
  • Ages > 18
  • All Genders

Study Summary

Aging is accompanied by a gradual alteration in the functional reserve of several organs and a change in body composition that can affect the pharmacokinetics, response, and safety profile of medications. Lidocaine is a local anesthetic used daily in perineural or intravenous administration to reduce the need for opioids. Although its analgesic efficacy is well-established, there is currently only one older study regarding the pharmacokinetics and pharmacokinetic-pharmacodynamic (PK-PD) relationship of lidocaine in healthy elderly patients. In this study, conducted with a small sample size (13 subjects over 64 years old and 24 young subjects under 38 years old) and using a low bolus of 25 mg, the half-life of lidocaine was increased by 59% and clearance was decreased by 35% in elderly male subjects without significant differences in females. However, the recommendations for intravenous administration of lidocaine for analgesic purposes are the same for all: a bolus of 1 to 2 mg/kg followed by continuous administration of 1.5 to 2 mg/kg/h. Morphine sparing is particularly important in elderly patients due to their increased sensitivity to adverse effects. With this study, the investigators aim to define the optimal dose to administer in elderly subjects, in order to optimize analgesia while remaining within the therapeutic range to limit the adverse effects of lidocaine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

CI1 - Adult participant (≤ 40 years old) and (≥ 70 years old). CI2 - Undergoing abdominal, digestive, hepatic, urological, or gynecological surgery with an expected duration > 2 hours.

CI3 - Covered by a social security plan. CI4 - Provided with both oral and written information about the protocol and has signed informed consent to participate in this research.

Exclusion

Exclusion Criteria:

NC1 - Allergy to lidocaine or any of its excipients.

NC2 - Presence of comorbidities that may alter lidocaine pharmacokinetics, such as:

  • Heart failure (ejection fraction < 45%).

  • Renal failure (creatinine clearance < 15 ml/min).

  • Hepatic failure (prothrombin time < 15%).

  • Body Mass Index (BMI) > 30.

NC3 - Long-term treatment with an antiarrhythmic drug.

NC4 - Ongoing treatment with strong CYP 1A2 inhibitors (e.g., Ciprofloxacin, Fluvoxamine) and/or CYP 1A2 inducers (e.g., Carbamazepine, Modafinil, Ritonavir).

NC5 - Use of peripheral or neuraxial regional anesthesia or local anesthetic infiltration.

NC6 - Known pregnancy or ongoing breastfeeding.

NC7 - Adult under legal protection (e.g., judicial safeguard, guardianship, or tutelage) or deprived of liberty.

NC8 - Participation in another interventional study.

EXCLUSION CRITERIA

EC1 - Any eligibility criterion that is no longer met between the signing of consent and the day of surgery.

EC2 - Participant with no blood sample for pharmacokinetics

Study Design

Total Participants: 64
Treatment Group(s): 7
Primary Treatment: Pharmacokinetic study of intravenous lidocaine
Phase: 4
Study Start date:
April 28, 2025
Estimated Completion Date:
February 01, 2027

Connect with a study center

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, CHU De Rennes 35033
    France

    Site Not Available

  • CHU de Rennes - Hôpital Sud

    Rennes, 35000
    France

    Active - Recruiting

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