Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Other)

Overall Status

Recruiting

CT.gov ID

NCT04584749

Collaborator

(none)

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

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

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

a phase IV, randomized, double-blind, two-arm, parallel-group clinical research triala 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 :

Nov 16, 2020

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 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 .

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

Outcome Measures

Primary Outcome Measures

Postoperative opioid consumption [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

Incidence of nausea and vomiting [24 hours]
Analyze the incidence of nausea and vomiting, paralytic ileus, time of return to oral diet and hospital stay.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Dr Josep Trueta	Girona		Spain	17007

Sponsors and Collaborators

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Oct 14, 2020

Last Update Posted:

Nov 17, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Lidocaine

Study Results

No Results Posted as of Nov 17, 2020