Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Lidocaine Iv

Study type: Interventional

Funder types: Other

Identifiers

NCT04584749

PROTOCOL LIDO

Details and patient eligibility

About

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

Full 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

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

LIDOCAINE

Experimental group

Description:

2% lidocaine 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. The study medication will be prepared in a 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing 2% Lidocaine as assigned by the patient. The syringes prepared by the pharmacy will be identical in all cases, with a label specifying the title of this test and the identification number of the patient

Treatment:

Drug: Lidocaine Iv

PLACEBO

Placebo Comparator group

Description:

0.9% physiological saline will be used as placebo, and it will be administered as a bolus during anesthetic induction . 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/placebo. The study medication will be prepared in a 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing Physiological Serum as assigned by the patient. The syringes prepared by the pharmacy will be identical in all cases, with a label specifying the title of this test and the identification number of the patient

Treatment:

Drug: Lidocaine Iv