Évaluation des concentrations plasmatiques de la lidocaïne intra veineuse et de la ropivacaïne utilisée par voie péridurale lors de leur association dans les chirurgies abdominales majeures.

Evaluation of plasma concentrations of intravenous lidocaine and epidural ropivacaine when used in combination in major abdominal surgery - LARA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005508-37-FR

Enrollment

Registered

2021-10-20

Start date

2021-12-20

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major abdominal surgery

Interventions

Trade Name: LIDOCAINE AGUETTANT 10 mg/ml Product Name: LIDOCAINE Pharmaceutical Form: Injection Trade Name: ROPIVACAINE ALTAN Product Name: ROPIVACAINE Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient undergoing major abdominal surgery with laparotomy - Age = 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: - Major abdominal surgery by laparoscopic route - Contraindication to the installation of a thoracic PDA - Contraindication to IV lidocaine - Contraindication to ropivacaine: allergy to LA, acute porphyria - Major hepatectomy with clamping

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the plasma concentrations of lidocaine and ropivacaine during the combination of perimedullary anesthesia and intravenous lidocaine during major abdominal surgery.;Secondary Objective: look for unwanted side effects associated with local anesthetics.;Primary end point(s): the plasma concentration of ropivacaine and lidocaine outside the safety range at different times of treatment. For lidocaine, the plasma safety range is 1.4 to 6 mg/ml, neurotoxicity appears from 15mg/ml, cardiotoxicity from 21 mg/ml. For ropivacaine, the usual total venous concentration not to be exceeded is around 2.2 microg.ml-1 ;Timepoint(s) of evaluation of this end point: 48 hours	—

Measure

Time frame

Main Objective: to assess the plasma concentrations of lidocaine and ropivacaine during the combination of perimedullary anesthesia and intravenous lidocaine during major abdominal surgery.;Secondary Objective: look for unwanted side effects associated with local anesthetics.;Primary end point(s): the plasma concentration of ropivacaine and lidocaine outside the safety range at different times of treatment. For lidocaine, the plasma safety range is 1.4 to 6 mg/ml, neurotoxicity appears from 15mg/ml, cardiotoxicity from 21 mg/ml. For ropivacaine, the usual total venous concentration not to be exceeded is around 2.2 microg.ml-1 ;Timepoint(s) of evaluation of this end point: 48 hours

—

Secondary

Measure	Time frame
Secondary end point(s): Investigation of clinical systemic toxicity to local anesthetics within 48 hours postoperatively;Timepoint(s) of evaluation of this end point: 48 hours	—

Countries

France

Contacts

Public ContactProject manager

CHU Amiens-Picardie

DRCI-Projets@chu-amiens.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026