NCT04584749

Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

Lidocaine as an Anesthetic Adjuvant in Upper Abdominal Laparoscopic Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 .

Timeline

• Start date: 2020-11-16
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2020-10-14
• Last updated: 2024-10-04

Locations

1 site across 1 country: Spain