Clinical trial

Correlation Between NoL Index Response to Standardized Stimulus Under General Anesthesia and: Post-operative Opioid Consumption and Pain, Pre-operative Phenotype and Pain Biomarkers

Name

Ciusss

Description

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).

Trial arms

Trial start

2018-01-15

Estimated PCD

2024-06-01

Trial end

2024-12-01

Status

Recruiting

Treatment

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

Arms:

Included patients

Catastrophizing score

Pre-operative catastrophizing score is correlated with post-operative pain and opioid consumption

Arms:

Included patients

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)

Arms:

Included patients

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 Blood samples will be withdrawn at D0 before surgery starts, D1 (H24) and D2 (H48) after surgery to see if they correlate with NOL changes after the stimulus described in intervention 1 above

Arms:

Included patients

Size

Primary endpoint

Correlation between NoL index and Hydromorphone consumption H24

Day 1 at 24 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective Pilot study', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 69, 'type': 'ESTIMATED'}}

Updated at

2023-10-18

1 organization

Organization

CIUSSS de l'Est de l'Île de Montréal