Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management

This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. The investigators hypothesize that NOL-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. Furthermore, the addition of intraoperative lidocaine in NOL-guided analgesia may further decrease opioid consumption.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anesthesia; Perioperative Care
• Intervention / Treatment: Drug: Lidocaine Intravenous Infusion; Device: NOL

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristiana Osoian; Phone Number: +40743352189; Email: osoiancris@yahoo.com

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania
      • Recruiting
      • Regional Gastroenterology and Hepatology Institute Octavian Fodor
      • Contact: Cristiana Osoian; Phone Number: +40743352189; Email: osoiancris@yahoo.com
      • Contact: Cristiana Osoian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age > 18 years
• ASA score I-III
• surgery for gastric or hepatobiliary or pancreatic neoplasia

Exclusion Criteria:

• pregnancy
• lactation
• neuraxial or regional anesthesia
• chronic treatment with drugs that can influence autonomic nervous system
• diuretics or nitroglycerin administration on the day of surgery
• severe neurological disability
• severe hemodynamic instability
• chronic pain
• chronic opioid treatment
• allergy to any of the study drugs
• severe untreated disease or organ failure
• pacemaker
• emergency surgery
• patient refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: + NOL + lidocaine group; NOL guided analgesia and intravenous lidocaine infusion	Drug: Lidocaine Intravenous Infusion; intravenous lidocaine 10 mg/ml continuous infusion; Device: NOL; Intraoperative Nociception Level index monitoring and guided analgesia
No Intervention: - NOL - lidocaine group; group without NOL monitoring or lidocaine administration
Experimental: + NOL - lidocaine group; NOL guided analgesia without intravenous lidocaine infusion	Device: NOL; Intraoperative Nociception Level index monitoring and guided analgesia
Experimental: - NOL + lidocaine group; group without NOL monitoring but with lidocaine intravenous infusion	Drug: Lidocaine Intravenous Infusion; intravenous lidocaine 10 mg/ml continuous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative opioid use	We aim to examine the effect nociception level index monitoring in major abdominal surgery on intraoperative nociception management by measuring total opioid use in NOL monitored patients vs standard care according to the anesthesiologists judgement. Moreover, crossreference interventional arms will examine the effect of intraoperative administration of lidocaine in NOL and no NOL groups on intraoperative opioid use. Intraoperative opioid use will be time adjusted ( depending on the duration of surgery) and weight adjusted (depending on the weight of the patient)- mg of opioid/hour/kg	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative pulse	Mean pulse rate and peak pulse rate	intraoperative
Intraoperative blood pressure	Mean blood pressure and peak blood pressure	intraoperative
Postoperative pain scores	VAS score at 15 minutes, 30 minute, 2 hours 4 hours, 12 hours and 24 hours	24 hours
Postoperative opioid use		24 hours
Lidocaine related adverse events		24 hours
Opioid related adverse events		24 hours

Collaborators and Investigators

• Sponsor: Osoian Cristiana

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: NOL-1047

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No