Skip to main content
OpenTrials
Completed

NCT Number: NCT04584749

Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

The aim is to analyze the effect of intravenous lidocaine administration on postoperative opioid use in patients undergoing upper abdominal cancer surgery. Specifically, those patients undergoing gastric cancer surgery and liver cancer surgery using a laparoscopic approach

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Dr Josep Trueta

Girona, 17007, Spain

About this study

In a recent Cochrane Library review, despite the apparent positive results reported by intravenous administration of lidocaine as a perioperative analgesic adjuvant, the quality of the evidence is low, since the studies carried out to date present small samples, great variability in the designs and different surgical techniques studied.

More studies will be needed to help improve the grade and quality of evidence in the management of acute postoperative pain and its role in opioid sparing, an especially beneficial effect in tumor pathology For this reason, the investigators have designed a randomized, double-blind, phase IV clinical trial with two treatment arms, parallel groups, in which 96 patients who underwent liver and gastric cancer surgery through laparoscopic approach participated.

This study will include 2 different population groups: patients undergoing liver cancer surgery and patients undergoing gastric cancer surgery

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women over 18 years of age scheduled for gastric or liver cancer surgery through a laparoscopic approach at the University of Girona Dr Josep Trueta.
  • Accept and sign the informed consent

Exclusion criteria

  • decline participating in the study at any stage of its development.
  • History of allergic or adverse reactions to Amide-type anesthetics.
  • Pregnancy or lactation period
  • Diagnosis of Child-Pugh stage B or C liver failure.
  • Acute renal failure (GFR <60 ml / min).
  • Concomitant treatment with opioids for chronic pain.
  • Any condition that, in the clinical judgment of the researchers, may interfere with the object of the research.

Treatment and study plan

Lidocaine IV

Drug

2% lidocaine or 0.9% physiological saline will be used as placebo, and it will be administered as a bolus during anesthetic induction equivalent to 1.5 mg / kg of lidocaine. After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine.

20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing 2% Lidocaine .

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: 24 Hours

    o evaluate the effect of intravenous lidocaine on postoperative pain after laparoscopic upper abdominal cancer surgery, analyzing postoperative opioid consumption

Secondary outcomes

  1. Incidence of nausea and vomiting

    Time frame: 24 hours

    Analyze the incidence of nausea and vomiting, paralytic ileus, time of return to oral diet and hospital stay.

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study title

Lidocaine as an Anesthetic Adjuvant in Upper Abdominal Laparoscopic Surgery

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
Oct 4, 2024

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.

Published trials that share one or more normalized conditions with this study.