Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients

Phase 4

Recruiting

• Conditions: Anesthesia
• Interventions: Other: Pre-inclusion; Other: Inclusion; Drug: Lidocaine; Other: Pharmacokinetic study of intravenous lidocaine; Other: Pain; Other: adverse effects/events; Biological: biological blood test

• Registration Number: NCT06795100
• Lead Sponsor: Rennes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-27
• Study Start: 2025-04-28
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
elderly patients	Pre-inclusion	Adult participant ≥ 70 years old
elderly patients	Inclusion	Adult participant ≥ 70 years old
elderly patients	Lidocaine	Adult participant ≥ 70 years old
elderly patients	Pharmacokinetic study of intravenous lidocaine	Adult participant ≥ 70 years old
elderly patients	Pain	Adult participant ≥ 70 years old
elderly patients	adverse effects/events	Adult participant ≥ 70 years old
elderly patients	biological blood test	Adult participant ≥ 70 years old
Young patients	Pre-inclusion	Adult participant ≤ 40 years old)
Young patients	Inclusion	Adult participant ≤ 40 years old)
Young patients	Lidocaine	Adult participant ≤ 40 years old)
Young patients	Pharmacokinetic study of intravenous lidocaine	Adult participant ≤ 40 years old)
Young patients	Pain	Adult participant ≤ 40 years old)
Young patients	adverse effects/events	Adult participant ≤ 40 years old)
Young patients	biological blood test	Adult participant ≤ 40 years old)

Primary Outcome Measures

Name	Time	Method
Plasma concentration of lidocaine	at 60 min from initial lidocaine bolus	Plasma concentration of lidocaine at steady state ( at 60 min from initial lidocaine bolus)

Secondary Outcome Measures

Name	Time	Method
Clearance	Day 0	Other pharmacokinetic parameters of lidocaine: clearance
Area under the curve	Day 0	Other pharmacokinetic parameters of lidocaine: area under the curve (AUC)
plasma half-life	Day 0	Other pharmacokinetic parameters of lidocaine: plasma half-life
Volume of distribution	Day 0	Other pharmacokinetic parameters of lidocaine: volume of distribution.
Free concentration	Day 0	Free concentration of lidocaine.
Total morphine-equivalent consumption	24 hours post-extubation.	Total morphine-equivalent consumption at 24 hours post-extubation.
Maximal pain reported in the post-anesthesia care unit (PACU)	Day 0	Maximal pain reported in the post-anesthesia care unit (PACU) assessed using the Numerical Rating Scale (NRS) for pain (Numerical scale from 0 to 10 (0: no pain, 10: worst pain ever experienced))
Maximal pain at rest in the 24h post-extubation	24 hours post-extubation	Maximal pain at rest in the 24h post-extubation, assessed using the Numerical Rating Scale (NRS) for pain. (Numerical scale from 0 to 10 (0: no pain, 10: worst pain ever experienced))
Maximal pain with movement in the 24h post-extubation	24 hours post-extubation	Maximal pain with movement in the 24h post-extubation, assessed using the Numerical Rating Scale (NRS) for pain (Numerical scale from 0 to 10 (0: no pain, 10: worst pain ever experienced))
Frequency of adverse effects	24 hours post-extubation	Frequency of adverse effects attributable to lidocaine at 24 hours post-extubation.
Number of adverse effects	24 hours post-extubation	Number of adverse effects attributable to lidocaine at 24 hours post-extubation.

Trial Locations

Locations (2)

CHU de Rennes - Hôpital Pontchaillou; 🇫🇷 Rennes, CHU De Rennes, France

CHU de Rennes - Hôpital Sud; 🇫🇷 Rennes, France