Study of how intravenous lidocaine works in young and elderly patients

Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients

This study tests how well intravenous lidocaine works for pain relief in young and elderly patients during surgery to see if age affects its effectiveness and how much should be given.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rennes University Hospital (other)
• Locations: 2 sites (Rennes, CHU de Rennes and 1 other locations)
• Trial ID: NCT06795100 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics of intravenous lidocaine in both young and elderly patients undergoing specific types of surgeries. It aims to understand how age affects the metabolism and effectiveness of lidocaine, a common local anesthetic. By comparing the responses of younger adults and older adults, the study seeks to optimize lidocaine dosing to improve pain management and reduce opioid use. Participants will be monitored for their response to lidocaine during and after surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 years or younger and those aged 70 years or older who are scheduled for specific surgeries lasting more than two hours.

Not a fit: Patients with allergies to lidocaine, significant comorbidities, or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for both young and elderly patients, minimizing the need for opioids.

How similar studies have performed: Previous studies have shown variations in lidocaine pharmacokinetics between young and elderly patients, but this study aims to provide more comprehensive data.

Eligibility criteria

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

Where this trial is running

Rennes, CHU de Rennes and 1 other locations

• CHU de Rennes - Hôpital Pontchaillou — Rennes, CHU de Rennes, France (NOT_YET_RECRUITING)
• CHU de Rennes - Hôpital Sud — Rennes, France (RECRUITING)

Study contacts

• Study coordinator: Marie LE NAOU

Conditions: Anesthesia