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

Osoian Cristiana160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

160

Conditions

Pain Anesthesia Perioperative Care

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: intraoperative

Secondary Outcomes

Intraoperative pulse

Mean pulse rate and peak pulse rate

Time frame: intraoperative

Intraoperative blood pressure

Mean blood pressure and peak blood pressure

Time frame: intraoperative

Postoperative pain scores

VAS score at 15 minutes, 30 minute, 2 hours 4 hours, 12 hours and 24 hours

Time frame: 24 hours

Postoperative opioid use

Time frame: 24 hours

Lidocaine related adverse events

Time frame: 24 hours

Opioid related adverse events

Time frame: 24 hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts