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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Ciusss de L'Est de l'Île de Montréal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Anesthesia
• Catastrophizing
• Nociceptive Pain

Interventions

Type	Name	Description
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
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2018-01-15
• Primary completion: 2024-03-07
• Completion: 2024-03-07
• First posted: 2018-02-06
• Last updated: 2024-07-17

Locations

1 site across 1 country: Canada