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

NCT03422783 | Terminated DMC

• 1 other identifier: 2017-1071
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain, Postoperative; Anesthesia; Catastrophizing; Nociceptive Pain

Keywords

Monitoring; Biomarker; Thoracoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Pain scores (NRS) in PACU from 0 to 10

  Day 0 at hour 2

• Correlation between NoL index and Pain scores (NRS from 0 to 10) in PACU

  Day 0 at hour 2

• Pain scores (NRS from 0 to 10) at H24 at rest

  Day 1 at 24 hours

• Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 at rest

  Day 1 at 24 hours

• Pain scores (NRS) at H24 while coughing from 0 to 10

  Day 1 at 24 hours

Study Arms (1)

Included patients

EXPERIMENTAL

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

Interventions

Standardized tetanic stimulation DEVICE

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

Included patients

Catastrophizing score DIAGNOSTIC_TEST

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

Included patients

Nociceptive threshold DIAGNOSTIC_TEST

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)

Included patients

Biomarkers BIOLOGICAL

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

Included patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (Age 18 or older)
• ASA status I, II or III
• elective video assisted thoracoscopy under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal

Montreal East, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Nociceptive Pain

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research in the Department of Anesthesiology

Model Details: Prospective Pilot study

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 6, 2018
• Study Start: January 15, 2018
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)