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Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Lidocaine Iv
Sponsored by
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Dr Josep TruetaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LIDOCAINE

PLACEBO

Arm 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

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

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
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
Analyze the incidence of nausea and vomiting, paralytic ileus, time of return to oral diet and hospital stay.

Full Information

First Posted
October 6, 2020
Last Updated
February 8, 2023
Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
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1. Study Identification

Unique Protocol Identification Number
NCT04584749
Brief Title
Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery
Official Title
Lidocaine as an Anesthetic Adjuvant in Upper Abdominal Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
a phase IV, randomized, double-blind, two-arm, parallel-group clinical research trial
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LIDOCAINE
Arm Type
Experimental
Arm 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
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Lidocaine Iv
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
o evaluate the effect of intravenous lidocaine on postoperative pain after laparoscopic upper abdominal cancer surgery, analyzing postoperative opioid consumption
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Incidence of nausea and vomiting
Description
Analyze the incidence of nausea and vomiting, paralytic ileus, time of return to oral diet and hospital stay.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Martinez, student PhD
Phone
34972940200
Ext
2343
Email
cmartinez@idibgi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillem Pla, MD
Organizational Affiliation
Hospital Dr Josep Trueta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Martinez, MSc
Phone
972940200
Ext
2343
Email
cmartinez@idibgi.org
First Name & Middle Initial & Last Name & Degree
Guillem Pla, MD
First Name & Middle Initial & Last Name & Degree
Ana Ricart, MD
First Name & Middle Initial & Last Name & Degree
Bernat Lloret, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

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