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

October 17, 2023 updated by: Philippe Richebe, Ciusss de L'Est de l'Île de Montréal

Correlation Between NoL Index Response to Standardized Stimulus Under General Anesthesia and: Post-operative Opioid Consumption and Pain, Pre-operative Phenotype and Pain Biomarkers

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).

Study Overview

Detailed Description

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

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Quebec
      • Montréal-Est, Quebec, Canada, H1T2M4
        • Recruiting
        • Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Included patients
There is only one arm in this study. Intervention will be electrical forearm stimulus under general anesthesia and the response of NOL index following this stimulus and its correlation with postoperative parameters such as pain and opioid consumption in post anesthesia care unit.

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

Pre-operative catastrophizing score is correlated with post-operative pain and opioid consumption
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)
Some biomarkers of inflammation and endogenous opioids are associated with post-operative pain. Blood samples will be withdrawn at D0 before surgery starts, D1 (H24) and D2 (H48) after surgery to see if they correlate with NOL changes after the stimulus described in intervention 1 above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between NoL index and Hydromorphone consumption H24
Time Frame: Day 1 at 24 hours
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Total hydromorphone consumption (PACU and PCA) 24h after surgery
Day 1 at 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores (NRS) in PACU from 0 to 10
Time Frame: Day 0 at hour 2
Pain scores from 0 to 10 after surgery, using numerical rating scale in post anesthesiology care unit
Day 0 at hour 2
Correlation between NoL index and Pain scores (NRS from 0 to 10) in PACU
Time Frame: Day 0 at hour 2
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores after surgery, in post anesthesiology care unit
Day 0 at hour 2
Pain scores (NRS from 0 to 10) at H24 at rest
Time Frame: Day 1 at 24 hours
Pain scores (NRS from 0 to 10) at H24 at rest
Day 1 at 24 hours
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 at rest
Time Frame: Day 1 at 24 hours
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H24 at rest
Day 1 at 24 hours
Pain scores (NRS) at H24 while coughing from 0 to 10
Time Frame: Day 1 at 24 hours
Pain scores (NRS) at H24 while coughing from 0 to 10
Day 1 at 24 hours
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 while coughing
Time Frame: Day 1 at 24 hours
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H24 while coughing
Day 1 at 24 hours
Pain scores (NRS) at H48 at rest from 0 to 10
Time Frame: Day 2 at 48 hours
Pain scores (NRS) at H48 at rest from 0 to 10
Day 2 at 48 hours
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 at rest
Time Frame: Day 2 at 48 hours
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H48 at rest
Day 2 at 48 hours
Pain scores (NRS) at H48 while coughing from 0 to 10
Time Frame: Day 2 at 48 hours
Pain scores (NRS) at H48 while coughing from 0 to 10
Day 2 at 48 hours
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 while coughing
Time Frame: Day 2 at 48 hours
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H48 while coughing
Day 2 at 48 hours
total hydromorphone consumption (mg) in PACU
Time Frame: Day 0 at 2 hours
general anesthesia and total hydromorphone consumption (mg) in PACU
Day 0 at 2 hours
Correlation between NoL index and total hydromorphone consumption (mg) in PACU
Time Frame: Day 0 at 2 hours
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and total hydromorphone consumption (mg) in PACU
Day 0 at 2 hours
Total hydromorphone consumption (mg) at H48
Time Frame: Day 2 at 48 hours
Total hydromorphone consumption (mg) at H48
Day 2 at 48 hours
Correlation between NoL index and total hydromorphone consumption (mg) at H48
Time Frame: Day 2 at 48 hours
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and total hydromorphone consumption (mg) at H48
Day 2 at 48 hours
Pain catastrophizing scale from 0 to 50 (fully validated and published questionnaire)
Time Frame: Pre-operative, 2 hours prior to surgery
Pain catastrophizing scale from 0 to 50
Pre-operative, 2 hours prior to surgery
Correlation between Pain catastrophizing scale from 0 to 50 and Total (hydromorphone consumption at day 1 24 hours)
Time Frame: Day 1 at 24 hours
Correlation between Pain catastrophizing scale and Total hydromorphone
Day 1 at 24 hours
Correlation between Pain catastrophizing scale from 0 to 50 and NoL index
Time Frame: Day 0
Correlation between pre-operative Pain catastrophizing scale and NoL index absolute values after electrical stimulus under general anesthesia
Day 0
State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)
Time Frame: Day 0
State-Trait anxiety Inventory from 0 to 80
Day 0
Correlation between State-Trait anxiety Inventory questionnaire from 0 to 80 and NoL index
Time Frame: Day 0
Correlation between pre-operative State-Trait anxiety Inventory and NoL index absolute values after electrical stimulus under general anesthesia
Day 0
Correlation between State-Trait anxiety Inventory from 0 to 80 and Total hydromorphone consumption at H24
Time Frame: Day 1 24 hours
Correlation between State-Trait anxiety Inventory and Total hydromorphone consumption at H24
Day 1 24 hours
mechanic pain threshold
Time Frame: Pre-operative, 2 hours prior to surgery
mechanic pain threshold using electronic Von Frey
Pre-operative, 2 hours prior to surgery
thermal pain threshold
Time Frame: Pre-operative, 2 hours prior to surgery
thermal pain threshold using Qsense device
Pre-operative, 2 hours prior to surgery
electrical pain threshold
Time Frame: Pre-operative, 2 hours prior to surgery
electrical pain threshold using Pain Matcher device
Pre-operative, 2 hours prior to surgery
Biomarkers level Pre-op
Time Frame: Pre-operative, H0 right after induction of general anesthesia
Biomarkers level Pre-op
Pre-operative, H0 right after induction of general anesthesia
Biomarkers level H24
Time Frame: Day 1 24 hours
Biomarkers level H24
Day 1 24 hours
Biomarkers level H48
Time Frame: Day 2 48 hours
Biomarkers level H48
Day 2 48 hours
Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)
Time Frame: 3 months
Brief Pain inventory (3M)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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