Pain, PostoperativeNCT03422783
Correlation Between NOL Index After Stimulus and Post-operative Opioid, Pain, Pre-operative Phenotype
A study testing Standardized tetanic stimulation, Catastrophizing score and Nociceptive threshold in people with Pain, Postoperative and Anesthesia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Catastrophizing
- What is being tested?
- Standardized tetanic stimulation, Catastrophizing score and Nociceptive threshold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2018to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (Age 18 or older)
- ASA status I, II or III
- elective video assisted thoracoscopy under general anesthesia
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
Montreal East, Quebec, H1T2M4
About this study
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
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).
Read the 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
- Being tested
- Standardized tetanic stimulation, Catastrophizing score, Nociceptive threshold, Biomarkers
- Keywords
- Monitoring, Biomarker, Thoracoscopy
- Medical subject headings
- Pain, Postoperative, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized tetanic stimulationDevice
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
Catastrophizing scoreDiagnostic test
Pre-operative catastrophizing score is correlated with post-operative pain and opioid consumption
Nociceptive thresholdDiagnostic 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)
BiomarkersBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Standardized tetanic stimulation; Diagnostic Test: Catastrophizing score; Diagnostic Test: Nociceptive threshold; Biological: Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 at 24 hours
Secondary outcomes (27)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 2 at 48 hours
total hydromorphone consumption (mg) in PACU
general anesthesia and total hydromorphone consumption (mg) in PACU
Measured: 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
Measured: Day 0 at 2 hours
Total hydromorphone consumption (mg) at H48
Total hydromorphone consumption (mg) at H48
Measured: 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
Measured: Day 2 at 48 hours
Pain catastrophizing scale from 0 to 50 (fully validated and published questionnaire)
Pain catastrophizing scale from 0 to 50
Measured: 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
Measured: 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
Measured: Day 0
State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)
State-Trait anxiety Inventory from 0 to 80
Measured: 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
Measured: 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
Measured: Day 1 24 hours
mechanic pain threshold
mechanic pain threshold using electronic Von Frey
Measured: Pre-operative, 2 hours prior to surgery
thermal pain threshold
thermal pain threshold using Qsense device
Measured: Pre-operative, 2 hours prior to surgery
electrical pain threshold
electrical pain threshold using Pain Matcher device
Measured: Pre-operative, 2 hours prior to surgery
Biomarkers level Pre-op
Biomarkers level Pre-op
Measured: Pre-operative, H0 right after induction of general anesthesia
Biomarkers level H24
Biomarkers level H24
Measured: Day 1 24 hours
Biomarkers level H48
Biomarkers level H48
Measured: Day 2 48 hours
Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)
Brief Pain inventory (3M)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start15 Jan 2018
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Why it stopped: Stopped in march 2024 because lead investigator left Canada
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Pilot study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422783
- Sponsor's protocol ID
- 2017-1071
- Status last verified
- Jul 2024
- First submitted
- 11 Jan 2018
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03422783
- Acronym / sponsor ID
- 2017-1071
- Conditions
- Pain, Postoperative, Anesthesia, Catastrophizing, Nociceptive Pain
- Keywords
- Monitoring, Biomarker, Thoracoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped in march 2024 because lead investigator left Canada
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Pilot study
| Arm | Type | Receives |
|---|---|---|
| Included patients | Experimental | Device: Standardized tetanic stimulation, Diagnostic Test: Catastrophizing score, Diagnostic Test: Nociceptive threshold, Biological: BiomarkersThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient (Age 18 or older)
- ASA status I, II or III
- elective video assisted thoracoscopy under general anesthesia
Key exclusion criteria (11 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized tetanic stimulationThe "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 | Device | Included patients |
| Catastrophizing scorePre-operative catastrophizing score is correlated with post-operative pain and opioid consumption | Diagnostic test | Included patients |
| Nociceptive thresholdNociceptive 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) | Diagnostic test | Included patients |
| BiomarkersSome 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 | Biological | Included patients |
Primary outcome
Correlation between NoL index and Hydromorphone consumption H24
Time frame: Day 1 at 24 hours
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Total hydromorphone consumption (PACU and PCA) 24h after surgery
27 secondary outcomes
Pain scores (NRS) in PACU from 0 to 10
Time frame: Day 0 at hour 2
Correlation between NoL index and Pain scores (NRS from 0 to 10) in PACU
Time frame: Day 0 at hour 2
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
Time frame: Day 1 at 24 hours
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
Time frame: Day 1 at 24 hours
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
Time frame: Day 2 at 48 hours
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
Time frame: Day 2 at 48 hours
total hydromorphone consumption (mg) in PACU
Time frame: Day 0 at 2 hours
Correlation between NoL index and total hydromorphone consumption (mg) in PACU
Time frame: Day 0 at 2 hours
Total hydromorphone consumption (mg) at H48
Time frame: Day 2 at 48 hours
Correlation between NoL index 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)
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)
Time frame: Day 1 at 24 hours
Correlation between Pain catastrophizing scale from 0 to 50 and NoL index
Time frame: Day 0
State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)
Time frame: Day 0
Correlation between State-Trait anxiety Inventory questionnaire from 0 to 80 and NoL index
Time frame: Day 0
Correlation between State-Trait anxiety Inventory from 0 to 80 and Total hydromorphone consumption at H24
Time frame: Day 1 24 hours
mechanic pain threshold
Time frame: Pre-operative, 2 hours prior to surgery
thermal pain threshold
Time frame: Pre-operative, 2 hours prior to surgery
electrical pain threshold
Time frame: Pre-operative, 2 hours prior to surgery
Biomarkers level Pre-op
Time frame: Pre-operative, H0 right after induction of general anesthesia
Biomarkers level H24
Time frame: Day 1 24 hours
Biomarkers level H48
Time frame: Day 2 48 hours
Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Stopped in march 2024 because lead investigator left Canada). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized tetanic stimulation, Catastrophizing score and Nociceptive threshold in people with Pain, Postoperative and Anesthesia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Stopped in march 2024 because lead investigator left Canada). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between NoL index and Hydromorphone consumption H24 (time frame: Day 1 at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.