Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

NCT ID: NCT04584749

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2023-04-01

Brief 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

Detailed 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

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LIDOCAINE

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

Group Type: EXPERIMENTAL

Lidocaine Iv

Intervention Type: 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 .

PLACEBO

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

Group Type: PLACEBO_COMPARATOR

Lidocaine Iv

Intervention Type: 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 .

Interventions

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 .

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role: lead

Responsible Party

Guillem Pla Escriva

Anesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillem Pla, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr Josep Trueta

Locations

Hospital Dr Josep Trueta

Girona, , Spain

Countries

Spain

Other Identifiers

PROTOCOL LIDO

Identifier Type: -

Identifier Source: org_study_id