Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

Pain, Postoperative Clinical Trial

Official title:

Lidocaine as an Anesthetic Adjuvant in Upper Abdominal Laparoscopic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584749
• Other study ID #: PROTOCOL LIDO
• Status: Recruiting
• Phase: Phase 4
• Start date: November 16, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2023
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Cristina Martinez, student PhD
• Phone: 34972940200
• Email: cmartinez[@]idibgi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Lidocaine Iv
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 .

Locations

Country	Name	City	State
Spain	Hospital Dr Josep Trueta	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	o evaluate the effect of intravenous lidocaine on postoperative pain after laparoscopic upper abdominal cancer surgery, analyzing postoperative opioid consumption	24 Hours
Secondary	Incidence of nausea and vomiting	Analyze the incidence of nausea and vomiting, paralytic ileus, time of return to oral diet and hospital stay.	24 hours