An interventional study of Standardized tetanic stimulation and Catastrophizing score in Pain, Postoperative, Anesthesia and Catastrophizing, sponsored by Ciusss de L'Est de l'Île de Montréal. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by Ciusss de L'Est de l'Île de Montréal · Not applicable, Interventional, and Diagnostic
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).
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.
5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 31 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Ciusss de L'Est de l'Île de Montréal is the lead sponsor of 88 studies on the registry; 30 are open to participants now.
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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.
Device: Standardized tetanic stimulation · Diagnostic Test: Catastrophizing score · Diagnostic Test: Nociceptive threshold · Biological: Biomarkers
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
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
Time frame: Day 1 at 24 hours
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
Time frame: Day 0 at hour 2
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
Time frame: Day 0 at hour 2
Pain scores (NRS from 0 to 10) at H24 at rest
Pain scores (NRS from 0 to 10) at H24 at rest
Time frame: Day 1 at 24 hours
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
Time frame: Day 1 at 24 hours
Pain scores (NRS) at H24 while coughing from 0 to 10
Pain scores (NRS) at H24 while coughing from 0 to 10
Time frame: Day 1 at 24 hours
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
Time frame: Day 1 at 24 hours
Pain scores (NRS) at H48 at rest from 0 to 10
Pain scores (NRS) at H48 at rest from 0 to 10
Time frame: Day 2 at 48 hours
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
Time frame: Day 2 at 48 hours
Pain scores (NRS) at H48 while coughing from 0 to 10
Pain scores (NRS) at H48 while coughing from 0 to 10
Time frame: Day 2 at 48 hours
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
Time frame: Day 2 at 48 hours
total hydromorphone consumption (mg) in PACU
general anesthesia and total hydromorphone consumption (mg) in PACU
Time frame: Day 0 at 2 hours
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
Time frame: Day 0 at 2 hours
Total hydromorphone consumption (mg) at H48
Total hydromorphone consumption (mg) at H48
Time frame: Day 2 at 48 hours
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
Time frame: Day 2 at 48 hours
Pain catastrophizing scale from 0 to 50 (fully validated and published questionnaire)
Pain catastrophizing scale from 0 to 50
Time frame: 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)
Correlation between Pain catastrophizing scale and Total hydromorphone
Time frame: Day 1 at 24 hours
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
Time frame: Day 0
State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)
State-Trait anxiety Inventory from 0 to 80
Time frame: Day 0
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
Time frame: Day 0
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
Time frame: Day 1 24 hours
mechanic pain threshold
mechanic pain threshold using electronic Von Frey
Time frame: Pre-operative, 2 hours prior to surgery
thermal pain threshold
thermal pain threshold using Qsense device
Time frame: Pre-operative, 2 hours prior to surgery
electrical pain threshold
electrical pain threshold using Pain Matcher device
Time frame: Pre-operative, 2 hours prior to surgery
Biomarkers level Pre-op
Biomarkers level Pre-op
Time frame: Pre-operative, H0 right after induction of general anesthesia
Biomarkers level H24
Biomarkers level H24
Time frame: Day 1 24 hours
Biomarkers level H48
Biomarkers level H48
Time frame: Day 2 48 hours
Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)
Brief Pain inventory (3M)
Time frame: 3 months
Plan to share: No
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Studies of the drug tested here: Biomarkers
Ciusss de L'Est de l'Île de Montréal