Correlation Between NOL Index After Stimulus and Post-operative Opioid, Pain, Pre-operative Phenotype
Primary Purpose
Pain, Postoperative, Anesthesia, Catastrophizing
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standardized tetanic stimulation
Catastrophizing score
Nociceptive threshold
Biomarkers
Sponsored by
About this trial
This is an interventional diagnostic trial for Pain, Postoperative focused on measuring Monitoring, Biomarker, Thoracoscopy
Eligibility Criteria
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
Sites / Locations
- Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de MontrealRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Included patients
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Pain scores (NRS from 0 to 10) at H24 at rest
Pain scores (NRS from 0 to 10) at H24 at rest
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
Pain scores (NRS) at H24 while coughing from 0 to 10
Pain scores (NRS) at H24 while coughing from 0 to 10
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
Pain scores (NRS) at H48 at rest from 0 to 10
Pain scores (NRS) at H48 at rest from 0 to 10
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 at rest
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H48 at rest
Pain scores (NRS) at H48 while coughing from 0 to 10
Pain scores (NRS) at H48 while coughing from 0 to 10
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 while coughing
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H48 while coughing
total hydromorphone consumption (mg) in PACU
general anesthesia and total hydromorphone consumption (mg) in PACU
Correlation between NoL index and total hydromorphone consumption (mg) in PACU
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and total hydromorphone consumption (mg) in PACU
Total hydromorphone consumption (mg) at H48
Total hydromorphone consumption (mg) at H48
Correlation between NoL index and total hydromorphone consumption (mg) at H48
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and total hydromorphone consumption (mg) at H48
Pain catastrophizing scale from 0 to 50 (fully validated and published questionnaire)
Pain catastrophizing scale from 0 to 50
Correlation between Pain catastrophizing scale from 0 to 50 and Total (hydromorphone consumption at day 1 24 hours)
Correlation between Pain catastrophizing scale and Total hydromorphone
Correlation between Pain catastrophizing scale from 0 to 50 and NoL index
Correlation between pre-operative Pain catastrophizing scale and NoL index absolute values after electrical stimulus under general anesthesia
State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)
State-Trait anxiety Inventory from 0 to 80
Correlation between State-Trait anxiety Inventory questionnaire from 0 to 80 and NoL index
Correlation between pre-operative State-Trait anxiety Inventory and NoL index absolute values after electrical stimulus under general anesthesia
Correlation between State-Trait anxiety Inventory from 0 to 80 and Total hydromorphone consumption at H24
Correlation between State-Trait anxiety Inventory and Total hydromorphone consumption at H24
mechanic pain threshold
mechanic pain threshold using electronic Von Frey
thermal pain threshold
thermal pain threshold using Qsense device
electrical pain threshold
electrical pain threshold using Pain Matcher device
Biomarkers level Pre-op
Biomarkers level Pre-op
Biomarkers level H24
Biomarkers level H24
Biomarkers level H48
Biomarkers level H48
Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)
Brief Pain inventory (3M)
Full Information
NCT ID
NCT03422783
First Posted
January 11, 2018
Last Updated
October 17, 2023
Sponsor
Ciusss de L'Est de l'Île de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT03422783
Brief Title
Correlation Between NOL Index After Stimulus and Post-operative Opioid, Pain, Pre-operative Phenotype
Official Title
Correlation Between NoL Index Response to Standardized Stimulus Under General Anesthesia and: Post-operative Opioid Consumption and Pain, Pre-operative Phenotype and Pain Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anesthesia, Catastrophizing, Nociceptive Pain
Keywords
Monitoring, Biomarker, Thoracoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Included patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standardized tetanic stimulation
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Catastrophizing score
Intervention Description
Pre-operative catastrophizing score is correlated with post-operative pain and opioid consumption
Intervention Type
Diagnostic Test
Intervention Name(s)
Nociceptive threshold
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Biomarkers
Intervention Description
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
Primary Outcome Measure Information:
Title
Correlation between NoL index and Hydromorphone consumption H24
Description
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 Outcome Measure Information:
Title
Pain scores (NRS) in PACU from 0 to 10
Description
Pain scores from 0 to 10 after surgery, using numerical rating scale in post anesthesiology care unit
Time Frame
Day 0 at hour 2
Title
Correlation between NoL index and Pain scores (NRS from 0 to 10) in PACU
Description
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
Title
Pain scores (NRS from 0 to 10) at H24 at rest
Description
Pain scores (NRS from 0 to 10) at H24 at rest
Time Frame
Day 1 at 24 hours
Title
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 at rest
Description
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
Title
Pain scores (NRS) at H24 while coughing from 0 to 10
Description
Pain scores (NRS) at H24 while coughing from 0 to 10
Time Frame
Day 1 at 24 hours
Title
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 while coughing
Description
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H24 while coughing
Time Frame
Day 1 at 24 hours
Title
Pain scores (NRS) at H48 at rest from 0 to 10
Description
Pain scores (NRS) at H48 at rest from 0 to 10
Time Frame
Day 2 at 48 hours
Title
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 at rest
Description
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H48 at rest
Time Frame
Day 2 at 48 hours
Title
Pain scores (NRS) at H48 while coughing from 0 to 10
Description
Pain scores (NRS) at H48 while coughing from 0 to 10
Time Frame
Day 2 at 48 hours
Title
Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 while coughing
Description
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H48 while coughing
Time Frame
Day 2 at 48 hours
Title
total hydromorphone consumption (mg) in PACU
Description
general anesthesia and total hydromorphone consumption (mg) in PACU
Time Frame
Day 0 at 2 hours
Title
Correlation between NoL index and total hydromorphone consumption (mg) in PACU
Description
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and total hydromorphone consumption (mg) in PACU
Time Frame
Day 0 at 2 hours
Title
Total hydromorphone consumption (mg) at H48
Description
Total hydromorphone consumption (mg) at H48
Time Frame
Day 2 at 48 hours
Title
Correlation between NoL index and total hydromorphone consumption (mg) at H48
Description
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and total hydromorphone consumption (mg) at H48
Time Frame
Day 2 at 48 hours
Title
Pain catastrophizing scale from 0 to 50 (fully validated and published questionnaire)
Description
Pain catastrophizing scale from 0 to 50
Time Frame
Pre-operative, 2 hours prior to surgery
Title
Correlation between Pain catastrophizing scale from 0 to 50 and Total (hydromorphone consumption at day 1 24 hours)
Description
Correlation between Pain catastrophizing scale and Total hydromorphone
Time Frame
Day 1 at 24 hours
Title
Correlation between Pain catastrophizing scale from 0 to 50 and NoL index
Description
Correlation between pre-operative Pain catastrophizing scale and NoL index absolute values after electrical stimulus under general anesthesia
Time Frame
Day 0
Title
State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)
Description
State-Trait anxiety Inventory from 0 to 80
Time Frame
Day 0
Title
Correlation between State-Trait anxiety Inventory questionnaire from 0 to 80 and NoL index
Description
Correlation between pre-operative State-Trait anxiety Inventory and NoL index absolute values after electrical stimulus under general anesthesia
Time Frame
Day 0
Title
Correlation between State-Trait anxiety Inventory from 0 to 80 and Total hydromorphone consumption at H24
Description
Correlation between State-Trait anxiety Inventory and Total hydromorphone consumption at H24
Time Frame
Day 1 24 hours
Title
mechanic pain threshold
Description
mechanic pain threshold using electronic Von Frey
Time Frame
Pre-operative, 2 hours prior to surgery
Title
thermal pain threshold
Description
thermal pain threshold using Qsense device
Time Frame
Pre-operative, 2 hours prior to surgery
Title
electrical pain threshold
Description
electrical pain threshold using Pain Matcher device
Time Frame
Pre-operative, 2 hours prior to surgery
Title
Biomarkers level Pre-op
Description
Biomarkers level Pre-op
Time Frame
Pre-operative, H0 right after induction of general anesthesia
Title
Biomarkers level H24
Description
Biomarkers level H24
Time Frame
Day 1 24 hours
Title
Biomarkers level H48
Description
Biomarkers level H48
Time Frame
Day 2 48 hours
Title
Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)
Description
Brief Pain inventory (3M)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia Godin
Phone
514-252-3400
Ext
4620
Email
ngodin.hmr@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Richebe, MD PhD
Phone
514-252-3400
Ext
4620
Email
philipperichebe@live.com
Facility Information:
Facility Name
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
City
Montréal-Est
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Godin
Phone
514-252-3400
Ext
3193
Email
ngodin.hmr@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Philippe Richebe, MD PhD
Phone
514-252-3400
Ext
4620
Email
philipperichebe@live.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Correlation Between NOL Index After Stimulus and Post-operative Opioid, Pain, Pre-operative Phenotype
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