- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03422783
Correlation Between NOL Index After Stimulus and Post-operative Opioid, Pain, Pre-operative Phenotype
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 Overview
Status
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philippe Richebe, MD PhD
- Phone Number: 4620 514-252-3400
- Email: philipperichebe@live.com
Study Contact Backup
- Name: Nadia Godin
- Phone Number: 4620 514-252-3400
- Email: ngodin.hmr@ssss.gouv.qc.ca
Study Locations
-
-
Quebec
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Montréal-Est, Quebec, Canada, H1T2M4
- Recruiting
- Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
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Contact:
- Philippe Richebe, MD PhD
- Phone Number: 4620 514-252-3400
- Email: philipperichebe@live.com
-
Contact:
- Nadia Godin
- Phone Number: 3193 514-252-3400
- Email: ngodin.hmr@ssss.gouv.qc.ca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
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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
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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
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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
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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
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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
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Day 2 at 48 hours
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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
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Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 while coughing
Time Frame: Day 2 at 48 hours
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Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Pain scores (NRS) at H48 while coughing
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Day 2 at 48 hours
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total hydromorphone consumption (mg) in PACU
Time Frame: Day 0 at 2 hours
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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
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Total hydromorphone consumption (mg) at H48
Time Frame: Day 2 at 48 hours
|
Total hydromorphone consumption (mg) at H48
|
Day 2 at 48 hours
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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
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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
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Pre-operative, 2 hours prior to surgery
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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
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Correlation between Pain catastrophizing scale and Total hydromorphone
|
Day 1 at 24 hours
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Correlation between Pain catastrophizing scale from 0 to 50 and NoL index
Time Frame: Day 0
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Correlation between pre-operative Pain catastrophizing scale and NoL index absolute values after electrical stimulus under general anesthesia
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Day 0
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State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)
Time Frame: Day 0
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State-Trait anxiety Inventory from 0 to 80
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Day 0
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Correlation between State-Trait anxiety Inventory questionnaire from 0 to 80 and NoL index
Time Frame: Day 0
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Correlation between pre-operative State-Trait anxiety Inventory and NoL index absolute values after electrical stimulus under general anesthesia
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Day 0
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Correlation between State-Trait anxiety Inventory from 0 to 80 and Total hydromorphone consumption at H24
Time Frame: Day 1 24 hours
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Correlation between State-Trait anxiety Inventory and Total hydromorphone consumption at H24
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Day 1 24 hours
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mechanic pain threshold
Time Frame: Pre-operative, 2 hours prior to surgery
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mechanic pain threshold using electronic Von Frey
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Pre-operative, 2 hours prior to surgery
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thermal pain threshold
Time Frame: Pre-operative, 2 hours prior to surgery
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thermal pain threshold using Qsense device
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Pre-operative, 2 hours prior to surgery
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electrical pain threshold
Time Frame: Pre-operative, 2 hours prior to surgery
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electrical pain threshold using Pain Matcher device
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Pre-operative, 2 hours prior to surgery
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Biomarkers level Pre-op
Time Frame: Pre-operative, H0 right after induction of general anesthesia
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Biomarkers level Pre-op
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Pre-operative, H0 right after induction of general anesthesia
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Biomarkers level H24
Time Frame: Day 1 24 hours
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Biomarkers level H24
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Day 1 24 hours
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Biomarkers level H48
Time Frame: Day 2 48 hours
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Biomarkers level H48
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Day 2 48 hours
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Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)
Time Frame: 3 months
|
Brief Pain inventory (3M)
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3 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ciusss
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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