Clinical trial NCT03422783: 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
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Postoperative
Anesthesia
Catastrophizing
Nociceptive Pain
Keywords: Monitoring
Biomarker
Thoracoscopy
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Pilot study
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Correlation between NoL index and Hydromorphone consumption H24
timeFrame: Day 1 at 24 hours
Secondary outcomes:
measure: Pain scores (NRS) in PACU from 0 to 10
timeFrame: Day 0 at hour 2
measure: Correlation between NoL index and Pain scores (NRS from 0 to 10) in PACU
timeFrame: Day 0 at hour 2
measure: Pain scores (NRS from 0 to 10) at H24 at rest
timeFrame: Day 1 at 24 hours
measure: Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 at rest
timeFrame: Day 1 at 24 hours
measure: Pain scores (NRS) at H24 while coughing from 0 to 10
timeFrame: Day 1 at 24 hours
measure: Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 while coughing
timeFrame: Day 1 at 24 hours
measure: Pain scores (NRS) at H48 at rest from 0 to 10
timeFrame: Day 2 at 48 hours
measure: Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 at rest
timeFrame: Day 2 at 48 hours
measure: Pain scores (NRS) at H48 while coughing from 0 to 10
timeFrame: Day 2 at 48 hours
measure: Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 while coughing
timeFrame: Day 2 at 48 hours
measure: total hydromorphone consumption (mg) in PACU
timeFrame: Day 0 at 2 hours
measure: Correlation between NoL index and total hydromorphone consumption (mg) in PACU
timeFrame: Day 0 at 2 hours
measure: Total hydromorphone consumption (mg) at H48
timeFrame: Day 2 at 48 hours
measure: Correlation between NoL index and total hydromorphone consumption (mg) at H48
timeFrame: Day 2 at 48 hours
measure: Pain catastrophizing scale from 0 to 50 (fully validated and published questionnaire)
timeFrame: Pre-operative, 2 hours prior to surgery
measure: Correlation between Pain catastrophizing scale from 0 to 50 and Total (hydromorphone consumption at day 1 24 hours)
timeFrame: Day 1 at 24 hours
measure: Correlation between Pain catastrophizing scale from 0 to 50 and NoL index
timeFrame: Day 0
measure: State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)
timeFrame: Day 0
measure: Correlation between State-Trait anxiety Inventory questionnaire from 0 to 80 and NoL index
timeFrame: Day 0
measure: Correlation between State-Trait anxiety Inventory from 0 to 80 and Total hydromorphone consumption at H24
timeFrame: Day 1 24 hours
measure: mechanic pain threshold
timeFrame: Pre-operative, 2 hours prior to surgery
measure: thermal pain threshold
timeFrame: Pre-operative, 2 hours prior to surgery
measure: electrical pain threshold
timeFrame: Pre-operative, 2 hours prior to surgery
measure: Biomarkers level Pre-op
timeFrame: Pre-operative, H0 right after induction of general anesthesia
measure: Biomarkers level H24
timeFrame: Day 1 24 hours
measure: Biomarkers level H48
timeFrame: Day 2 48 hours
measure: Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)
timeFrame: 3 months
Other outcomes:
Locations:
city: Montréal-Est
country: Canada
facility: Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
state: Quebec
Study officials:
References: