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

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 4

Conditions: Thoracic Epidural Analgesia; Lidocaine Adverse Reaction; Abdominal Surgery by Laparotomy; Analgesia

Treatments: Drug: Lidocain; Drug: ropivacaine; Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT05368753

PI2021_843_0197

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Abdominal surgery by laparotomy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

thoracic epidural analgesia

Experimental group

Description:

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

Treatment:

Other: Blood sample

Drug: ropivacaine

Drug: Lidocain