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

NCT05368753 | Completed Phase 4

• 1 other identifier: PI2021_843_0197
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Abdominal surgery by laparotomy; thoracic epidural analgesia; Analgesia; Lidocaine Adverse Reaction

Outcome Measures

Primary Outcomes (4)

• Blood lidocaine concentration (micrograms/ml)

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

  30 minutes before the end of surgery

• blood lidocaine concentration (micrograms/ml)

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

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

• blood lidocaine and ropivacaine concentration (micrograms/ml)

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

  at 2 hours

• blood ropivacaine concentration (micrograms/ml)

  ropivacaine blood sample 24h after the infusion of the TEA

  at 24 hours

Study Arms (1)

thoracic epidural analgesia

EXPERIMENTAL

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

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

Interventions

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

thoracic epidural analgesia

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.

thoracic epidural analgesia

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.

thoracic epidural analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Abdominal surgery by laparotomy

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Agnosia

Interventions

Blood Specimen Collection; Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: May 10, 2022
• Study Start: March 9, 2022
• Primary Completion: January 28, 2024
• Study Completion: October 2, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)