CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 51 enrolled
Drug / intervention
Lidocain +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05368753
NCT05368753Phase 4Completed

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

Centre Hospitalier Universitaire, Amiens·interventional·Posted May 10, 2022·Updated Nov 19, 2025

In Brief

A Phase 4 clinical trial evaluating Blood sample, Lidocain, and 1 other intervention for Abdominal Surgery by Laparotomy and 3 related conditions. Completed, enrolled 51 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMay 10, 2022
Enrollment StartMar 9, 2022
Primary CompletionJan 28, 2024
Study CompletionOct 2, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.1 years ago

Interventions

Blood sampleother

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

Lidocaindrug

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.

ropivacainedrug

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.