Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

NCT04584749 | Completed Phase 4

• 1 other identifier: PROTOCOL LIDO
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of nausea and vomiting

  24 hours

Study Arms (2)

LIDOCAINE

EXPERIMENTAL

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

PLACEBO

PLACEBO COMPARATOR

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

Interventions

Lidocaine Iv 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 .

LIDOCAINE; PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Hospital Dr Josep Trueta

Girona, 17007, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Guillem Pla, MD

  Hospital Dr Josep Trueta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthetist

Model Details: a phase IV, randomized, double-blind, two-arm, parallel-group clinical research trial

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: November 16, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)