Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

• ClinicalTrials.gov Identifier: NCT04584749
• Recruitment Status: Recruiting
• First Posted: October 14, 2020
• Last Update Posted: November 17, 2020
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Information provided by (Responsible Party): Guillem Pla Escriva, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study Description

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

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative	Drug: Lidocaine Iv	Phase 4

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: a phase IV, randomized, double-blind, two-arm, parallel-group clinical research trial
• Masking: Double (Participant, Investigator)

Masking Description

Patients will be randomized in a 1: 1 ratio to one of two treatment groups: Lidocaine or Placebo.

To preserve the masking of the study, the list with the recruited patients will be sent weekly to an independent researcher from IDIBGI, who will be in charge of providing the names and numbers of the medical records to the pharmacy service.

The randomization process has been carried out using the PASS 16.0.4 program. Only the Pharmacy staff will know the randomization tables and codes. The main investigator will have the emergency codes in case of need

• Primary Purpose: Treatment
• Official Title: Lidocaine as an Anesthetic Adjuvant in Upper Abdominal Laparoscopic Surgery
• Actual Study Start Date: November 16, 2020
• Estimated Primary Completion Date: October 1, 2021
• Estimated Study Completion Date: October 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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 .
Placebo Comparator: 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	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 .

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Cristina Martinez, student PhD; 34972940200 ext 2343; cmartinez@idibgi.org

Locations

Spain

Hospital Dr Josep Trueta; Recruiting

Girona, Spain, 17007

Contact: Cristina Martinez, MSc 972940200 ext 2343 cmartinez@idibgi.org

Principal Investigator: Guillem Pla, MD

Sub-Investigator: Ana Ricart, MD

Sub-Investigator: Bernat Lloret, MD

Sponsors and Collaborators

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Investigators

• Principal Investigator: Guillem Pla, MD; Hospital Dr Josep Trueta

More Information

• Responsible Party: Guillem Pla Escriva, Anesthetist, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• ClinicalTrials.gov Identifier: NCT04584749
• Other Study ID Numbers: PROTOCOL LIDO
• First Posted: October 14, 2020
• Last Update Posted: November 17, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action