AnesthesiaPhase 4ElderLIDO_1NCT06795100
Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients
A Phase 4 study testing Pre-inclusion, Inclusion and Lidocaine in people with Anesthesia, run by Rennes University Hospital at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Pre-inclusion, Inclusion and Lidocaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Apr 2025to 26 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Rennes - Hôpital Pontchaillou
Rennes, CHU de Rennes, 35033
CHU de Rennes - Hôpital Sud
Rennes, 35000
About this study
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
- Being tested
- Pre-inclusion, Inclusion, Lidocaine, Pharmacokinetic study of intravenous lidocaine, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-inclusionOther
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.
InclusionOther
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.
LidocaineDrug
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 lidocaineOther
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.
PainOther
. 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/eventsOther
Any adverse effects/events will be documented from the start of lidocaine administration until 24 hours post-extubation,
biological blood testBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| elderly patients | Other | Adult participant ≥ 70 years old Receives: 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) Receives: Other: Pre-inclusion; Other: Inclusion; Drug: Lidocaine; Other: Pharmacokinetic study of intravenous lidocaine; Other: Pain; Other: adverse effects/events; Biological: biological blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of lidocaine
Plasma concentration of lidocaine at steady state ( at 60 min from initial lidocaine bolus)
Measured: at 60 min from initial lidocaine bolus
Secondary outcomes (11)
Clearance
Other pharmacokinetic parameters of lidocaine: clearance
Measured: Day 0
Area under the curve
Other pharmacokinetic parameters of lidocaine: area under the curve (AUC)
Measured: Day 0
plasma half-life
Other pharmacokinetic parameters of lidocaine: plasma half-life
Measured: Day 0
Volume of distribution
Other pharmacokinetic parameters of lidocaine: volume of distribution.
Measured: Day 0
Free concentration
Free concentration of lidocaine.
Measured: Day 0
Total morphine-equivalent consumption
Total morphine-equivalent consumption at 24 hours post-extubation.
Measured: 24 hours post-extubation.
Maximal pain reported in the post-anesthesia care unit (PACU)
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))
Measured: Day 0
Maximal pain at rest in the 24h 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))
Measured: 24 hours post-extubation
Maximal pain with movement in the 24h 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))
Measured: 24 hours post-extubation
Frequency of adverse effects
Frequency of adverse effects attributable to lidocaine at 24 hours post-extubation.
Measured: 24 hours post-extubation
Number of adverse effects
Number of adverse effects attributable to lidocaine at 24 hours post-extubation.
Measured: 24 hours post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start28 Apr 2025
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795100
- Sponsor's protocol ID
- 35RC23_9774_07_ElderLIDO_1
- Acronym
- ElderLIDO_1
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients
- ClinicalTrials.gov ID
- NCT06795100
- Acronym / sponsor ID
- ElderLIDO_1 / 35RC23_9774_07_ElderLIDO_1
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elderly patients | Other | Other: Pre-inclusion, Other: Inclusion, Drug: Lidocaine, Other: Pharmacokinetic study of intravenous lidocaine, Other: Pain, Other: adverse effects/events, Biological: biological blood testAdult participant ≥ 70 years old |
| Young patients | Other | Other: Pre-inclusion, Other: Inclusion, Drug: Lidocaine, Other: Pharmacokinetic study of intravenous lidocaine, Other: Pain, Other: adverse effects/events, Biological: biological blood testAdult participant ≤ 40 years old) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- NC1 - Allergy to lidocaine or any of its excipients.
- Heart failure (ejection fraction < 45%).
- Renal failure (creatinine clearance < 15 ml/min).
- Hepatic failure (prothrombin time < 15%).
- Body Mass Index (BMI) > 30.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-inclusionInformation 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. | Other | Young patients, elderly patients |
| InclusionParticipants 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. | Other | Young patients, elderly patients |
| LidocaineInduction 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. | Drug | Young patients, elderly patients |
| Pharmacokinetic study of intravenous lidocaineBlood 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. | Other | Young patients, elderly patients |
| 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. | Other | Young patients, elderly patients |
| adverse effects/eventsAny adverse effects/events will be documented from the start of lidocaine administration until 24 hours post-extubation, | Other | Young patients, elderly patients |
| biological blood testA 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. | Biological | Young patients, elderly patients |
Primary outcome
Plasma concentration of lidocaine
Time frame: at 60 min from initial lidocaine bolus
Plasma concentration of lidocaine at steady state ( at 60 min from initial lidocaine bolus)
11 secondary outcomes
Clearance
Time frame: Day 0
Area under the curve
Time frame: Day 0
plasma half-life
Time frame: Day 0
Volume of distribution
Time frame: Day 0
Free concentration
Time frame: Day 0
Total morphine-equivalent consumption
Time frame: 24 hours post-extubation.
Maximal pain reported in the post-anesthesia care unit (PACU)
Time frame: Day 0
Maximal pain at rest in the 24h post-extubation
Time frame: 24 hours post-extubation
Maximal pain with movement in the 24h post-extubation
Time frame: 24 hours post-extubation
Frequency of adverse effects
Time frame: 24 hours post-extubation
Number of adverse effects
Time frame: 24 hours post-extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pre-inclusion, Inclusion and Lidocaine in people with Anesthesia, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of lidocaine (time frame: at 60 min from initial lidocaine bolus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.