Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients

NCT06795100 | Recruiting Phase 4

• 1 other identifier: 35RC23_9774_07_ElderLIDO_1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of lidocaine

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

  at 60 min from initial lidocaine bolus

Secondary Outcomes (11)

• Clearance

  Day 0

• Area under the curve

  Day 0

• plasma half-life

  Day 0

• Volume of distribution

  Day 0

• Free concentration

  Day 0

Study Arms (2)

elderly patients

OTHER

Adult participant ≥ 70 years old

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

Young patients

OTHER

Adult participant ≤ 40 years old)

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

Interventions

Pre-inclusion OTHER

Information and presentation of the proposed study to participants during the anesthesia consultation scheduled prior to surgery, including provision of the information document and consent form. Trial participants will have at least 2 days to decide whether or not to take part in the trial.

Young patients; elderly patients

Inclusion OTHER

Participants will be welcomed according to the usual process in the digestive, hepatic, urological, or gynecological surgery service. The inclusion visit will coincide with the pre-anesthesia visit during which the absence of contraindications for starting the study will be verified, particularly the occurrence of any health changes since the anesthesia visit that would contraindicate anesthesia or lidocaine administration. During this visit, participant consent will be obtained. The informed consent form must be signed no later than the morning of the intervention. For women of childbearing age, the absence of current pregnancy will be verified orally for each participant included. A pregnancy test may be performed if the participant so wishes, but a systematic test is not justified.

Young patients; elderly patients

Lidocaine DRUG

Induction of anesthesia will be at the discretion of the attending anesthesiologist, with a lidocaine bolus of 2 mg/kg administered over 1 minute, followed by a continuous IV infusion of 2 mg/kg/h.

Young patients; elderly patients

Pharmacokinetic study of intravenous lidocaine OTHER

Blood samples of 3 mL will be collected in heparinized tubes without gel of 4 ml at 30, 60 and 120 minutes after the start of lidocaine infusion, then every two hours during surgery, and two finals samples at 15 and 60 minutes after the infusion stops.

Young patients; elderly patients

Pain OTHER

. Maximal pain reported in the post-anesthesia care unit (PACU) and maximal pain at rest and with movement at 24 hours post-extubation will be recorded.

Young patients; elderly patients

adverse effects/events OTHER

Any adverse effects/events will be documented from the start of lidocaine administration until 24 hours post-extubation,

Young patients; elderly patients

biological blood test BIOLOGICAL

A biological blood test, not performed in routine practice, will be carried out to measure the following parameters: albumin, ASAT, ALAT, PAL, GammaGT, total and conjugated bilirubin, creatinine, with calculation of GFR.

Young patients; elderly patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (2)

CHU de Rennes - Hôpital Pontchaillou

Rennes, CHU de Rennes, 35033, France

NOT YET RECRUITING

CHU de Rennes - Hôpital Sud

Rennes, 35000, France

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Marie LE NAOU

CONTACT

0299282555; marie.lenaou@chu-rennes.fr

Pauline Rouxel, MD

CONTACT

0299266724; pauline.rouxel@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 27, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 2, 2025

Record last verified: 2024-12

Locations

FR (2)