Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2027-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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elderly patients

Adult participant ≥ 70 years old

Group Type OTHER

Pre-inclusion

Intervention Type 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.

Inclusion

Intervention Type 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.

Lidocaine

Intervention Type 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.

Pharmacokinetic study of intravenous lidocaine

Intervention Type 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.

Pain

Intervention Type 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.

adverse effects/events

Intervention Type OTHER

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

biological blood test

Intervention Type 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

Adult participant ≤ 40 years old)

Group Type OTHER

Pre-inclusion

Intervention Type 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.

Inclusion

Intervention Type 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.

Lidocaine

Intervention Type 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.

Pharmacokinetic study of intravenous lidocaine

Intervention Type 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.

Pain

Intervention Type 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.

adverse effects/events

Intervention Type OTHER

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

biological blood test

Intervention Type 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.

Interventions

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Pre-inclusion

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.

Intervention Type OTHER

Inclusion

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.

Intervention Type OTHER

Lidocaine

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.

Intervention Type DRUG

Pharmacokinetic study of intravenous lidocaine

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.

Intervention Type OTHER

Pain

. 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.

Intervention Type OTHER

adverse effects/events

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

Intervention Type OTHER

biological blood test

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No