Correlation Between NOL Index After Stimulus and Post-operative Opioid, Pain, Pre-operative Phenotype

Ciusss de L'Est de l'Île de Montréal31 enrolled

Overview

This study evaluates the correlation between NoL index response to standardized stimulus under general anesthesia and the post-operative pain, assessed by opioid consumption and numerical pain scores after video-assisted thoracoscopy (VATS).

The NoL index, a nociception monitor using a multiparametric approach, has shown an excellent sensitivity and specificity in detecting noxious stimuli under general anesthesia. This monitor is better than any other parameter in grading nociception under general anesthesia. More recently, it has recently been shown a strong correlation between NoL index response to nociceptive stimulus and the level of opioid analgesia during surgery. No study has evaluated that NoL could predict post-operative pain so far. It has not yet been proven that NoL was correlated with post-operative opioid consumption or with post-operative pain scores. Some phenotypic factors were previously shown to correlate with post-operative pain and opioid consumption, such as psychological factors and tests, or also assessment of some pre-operative nociceptive thresholds (NT). Pain catastrophizing was proven in several studies to correlate with acute post-operative pain. So far, no study compared each of these preoperative psychological factors or nociceptif thresholds to the NoL index response to intraoperative standardized pain stimulus in terms of correlation with post-operative opioid requirements and pain scores. Moreover, there is no study evaluating the pro-inflammatory protein profiles that might likely be correlated to inter-individual differences in NoL response after this standardized nociceptive stimulus under general anesthesia. This study will assess the level of correlation between NoL index response to standardized stimulus under general anesthesia and the post-operative pain, assessed by opioid consumption and numerical pain scores after video-assisted thoracoscopy (VATS). It also evaluates the correlation between NoL index response to standardized stimulus under general anesthesia and pre-operative phenotype and post-operative pain biomarkers.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pain, Postoperative Anesthesia Catastrophizing Nociceptive Pain

Interventions

Standardized tetanic stimulationDEVICE

The "intervention" is not a drug, but it is standardized electrical stimulus applied with a muscle relaxation monitor on the forearm of the anesthetized patient. The NoL index is registered in response to this stimulus in an observational manner. Device: Device PMD200TM offering intraoperative NoL Index

Catastrophizing scoreDIAGNOSTIC_TEST

Pre-operative catastrophizing score is correlated with post-operative pain and opioid consumption

Nociceptive thresholdDIAGNOSTIC_TEST

Nociceptive threshold for pressure, heat and electrical stimulation are associated with post-operative pain and will be assessed preoperatively to see if there is correlation between them and the NOL index response to the nociceptive stimulus (see intervention 1)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient (Age 18 or older) * ASA status I, II or III * elective video assisted thoracoscopy under general anesthesia Exclusion Criteria: * history of coronary artery disease * serious cardiac arrhythmia (including atrial fibrillation), * history of substance abuse, * chronic use of psychotropic and/or opioid drugs, * use of drugs that act on the autonomic nervous system (including β-blockers), * history of psychiatric diseases, * allergy to any drug used in the study protocol, * refusal of the patient * unexpected difficult airway requesting excessive, possibly painful airway manipulations * unexpected intraoperative complications requiring strong hemodynamic support (transfusions, vasopressors, inotropes) * conversion to thoracotomy

Locations (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal

Montreal East, Quebec, Canada

Outcomes

Primary Outcomes

Correlation between NoL index and Hydromorphone consumption H24

Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Total hydromorphone consumption (PACU and PCA) 24h after surgery

Time frame: Day 1 at 24 hours

Secondary Outcomes

Pain scores (NRS) in PACU from 0 to 10

Pain scores from 0 to 10 after surgery, using numerical rating scale in post anesthesiology care unit

Time frame: Day 0 at hour 2

Correlation between NoL index and Pain scores (NRS from 0 to 10) in PACU

Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores after surgery, in post anesthesiology care unit

Time frame: Day 0 at hour 2

Pain scores (NRS from 0 to 10) at H24 at rest

Time frame: Day 1 at 24 hours

Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 at rest

Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H24 at rest

Time frame: Day 1 at 24 hours

Pain scores (NRS) at H24 while coughing from 0 to 10

Time frame: Day 1 at 24 hours

Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 while coughing

Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H24 while coughing

Data from ClinicalTrials.gov

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