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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03422783
• Other study ID #: Ciusss
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: Nadia Godin
• Phone: 514-252-3400
• Email: ngodin.hmr[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Anesthesia
• Catastrophizing
• Nociceptive Pain
• Pain, Postoperative

Intervention

Device:
• Standardized tetanic stimulation
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

Diagnostic Test:
• Catastrophizing score
Pre-operative catastrophizing score is correlated with post-operative pain and opioid consumption
• Nociceptive threshold
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)

Biological:
• Biomarkers
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

Locations

Country	Name	City	State
Canada	Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal	Montréal-Est	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1 at 24 hours
Secondary	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	Day 0 at hour 2
Secondary	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	Day 0 at hour 2
Secondary	Pain scores (NRS from 0 to 10) at H24 at rest	Pain scores (NRS from 0 to 10) at H24 at rest	Day 1 at 24 hours
Secondary	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	Day 1 at 24 hours
Secondary	Pain scores (NRS) at H24 while coughing from 0 to 10	Pain scores (NRS) at H24 while coughing from 0 to 10	Day 1 at 24 hours
Secondary	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	Day 1 at 24 hours
Secondary	Pain scores (NRS) at H48 at rest from 0 to 10	Pain scores (NRS) at H48 at rest from 0 to 10	Day 2 at 48 hours
Secondary	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	Day 2 at 48 hours
Secondary	Pain scores (NRS) at H48 while coughing from 0 to 10	Pain scores (NRS) at H48 while coughing from 0 to 10	Day 2 at 48 hours
Secondary	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	Day 2 at 48 hours
Secondary	total hydromorphone consumption (mg) in PACU	general anesthesia and total hydromorphone consumption (mg) in PACU	Day 0 at 2 hours
Secondary	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	Day 0 at 2 hours
Secondary	Total hydromorphone consumption (mg) at H48	Total hydromorphone consumption (mg) at H48	Day 2 at 48 hours
Secondary	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	Day 2 at 48 hours
Secondary	Pain catastrophizing scale from 0 to 50 (fully validated and published questionnaire)	Pain catastrophizing scale from 0 to 50	Pre-operative, 2 hours prior to surgery
Secondary	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	Day 1 at 24 hours
Secondary	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	Day 0
Secondary	State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)	State-Trait anxiety Inventory from 0 to 80	Day 0
Secondary	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	Day 0
Secondary	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	Day 1 24 hours
Secondary	mechanic pain threshold	mechanic pain threshold using electronic Von Frey	Pre-operative, 2 hours prior to surgery
Secondary	thermal pain threshold	thermal pain threshold using Qsense device	Pre-operative, 2 hours prior to surgery
Secondary	electrical pain threshold	electrical pain threshold using Pain Matcher device	Pre-operative, 2 hours prior to surgery
Secondary	Biomarkers level Pre-op	Biomarkers level Pre-op	Pre-operative, H0 right after induction of general anesthesia
Secondary	Biomarkers level H24	Biomarkers level H24	Day 1 24 hours
Secondary	Biomarkers level H48	Biomarkers level H48	Day 2 48 hours
Secondary	Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)	Brief Pain inventory (3M)	3 months