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OpenTrials
Completed

NCT Number: NCT05368753

Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery

Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period.

Side effects can be paralytic ileus or nausea and vomiting and delay the enhanced recovery after surgery.

Intravenous lidocaine and TEA share several properties like anti hyperalgesia, anti inflammatory effect, intestinal process, anti tumoral effect… which suggests an additive effect of their combination that was not studied yet.

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Key information

Conditions

Abdominal Surgery by Laparotomy Agnosia Analgesia Lidocaine Adverse Reaction Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Thoracic Epidural Analgesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Amiens

Amiens, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Abdominal surgery by laparotomy

Exclusion criteria

  • laparoscopic abdominal surgery,
  • TEA contraindication,
  • ropivacaine contraindication
  • intravenous lidocaine contraindication

Treatment and study plan

blood sample

Other

Lidocaine blood sample 30 min before the end of the surgery Lidocaine blood sample at the end of the infusion lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA Ropivacaine blood sample 24h after the infusion of the TEA

Lidocain

Drug

Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end) The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.

Ropivacaine

Drug

Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.

Primary outcomes

  1. Blood lidocaine concentration (micrograms/ml)

    Time frame: 30 minutes before the end of surgery

    Lidocaine blood sample will be performed 30 min before the end of the surgery

  2. blood lidocaine concentration (micrograms/ml)

    Time frame: at the end of the surgery (assessed up to 2 hours)

    lidocaine blood sample will be performed at the end of the infusion,

  3. blood lidocaine and ropivacaine concentration (micrograms/ml)

    Time frame: at 2 hours

    lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA,

  4. blood ropivacaine concentration (micrograms/ml)

    Time frame: at 24 hours

    ropivacaine blood sample 24h after the infusion of the TEA

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: LARA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 10, 2022
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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