Nociceptive PainALGOBLOC-1NCT04925336
Cerebral and Autonomic Responses to Pain in Healthy Humans
A study testing Nociceptive stimulation in people with Nociceptive Pain and Anesthesia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Evaluating the intraoperative pain is a major challenge for the anesthesia team. During anesthesia, changes in heart rate and blood pressure are interpreted qualitatively to evaluate the sympathetic response to nociceptive stimulation or the adaptation of analgesia during surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nociceptive Pain, Anesthesia, Healthy
- What is being tested?
- Nociceptive stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2021to 8 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer over 18 years old
- signed informed consent
- affiliated to a social security
Who cannot join
- Chronic pathology requiring chronic treatment
- Cardiac rhythm disorders, pacemaker, cardiotropic treatment
- Taking opioid analgesics during the previous week
- Painful chronic, or migraine
- Pathology of the hand, acrosyndrome, carpal tunnel syndrome
- Pregnancy
- People placed under protection of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Neurologie Fonctionnelle et Epileptologie Hôpital Neurologique, GHE Hospices civils de Lyon
Bron, 69677
About this study
Official title: Study of Cortical Cerebral Response and Neurovegetative Response to a Nociceptive Stimulus Among Healthy Volunteers
Evaluating the intraoperative pain is a major challenge for the anesthesia team. During anesthesia, changes in heart rate and blood pressure are interpreted qualitatively to evaluate the sympathetic response to nociceptive stimulation or the adaptation of analgesia during surgery. The new nociception monitors under development quantitatively explore other variables dependent on sympathetic activity or sympathetic / parasympathetic balance, such as the pulse wave amplitude measurement (Surgical Pleth Index (SPI index)), the pupil dilation reflex, respiratory sinus arrhythmia (ANI, Analgesia Nociception Index), or skin conductance index. Taken independently, these tools provide an assessment of nociception based on variations in the autonomic system, more robust than simply observing heart rate or blood pressure raw values.
However, the relationship between variations in the neurovegetative system and pain can be compromised by various factors or intraoperative events such as hypovolemia, bleeding, certain sympathomimetic or sympatholytic treatments, the hypnosis depth, ventilation variation, fast filling, or body temperature. Moreover, investigators do not know the delay between the application of the painful stimulus and the observation of the variation of the different neurovegetative variables. This constitutes a limit of the practitioners' confidence in these monitoring tools.
The nociception transmission pathways of to the vegetative centers and cortical areas are complex. Investigators hypothesis is that neurovegetative variations in response to nociceptive stimulation are not always associated with a cortical somatosensory response. In this project investigators investigate the relation between cortical (EEG) and vegetative reactions to acute and tonic nociceptive stimuli, as a preliminary step to apply these procedures to assess intraoperative reactions to nociceptive procedures in anesthetized patients.
- Conditions
- Nociceptive Pain, Anesthesia, Healthy
- Being tested
- Nociceptive stimulation
- Keywords
- Nociceptive stimulation, Healthy volunteer, Simultaneous cortical activation, Neuro-vegetative response
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nociceptive stimulationOther
These investigations in healthy volunteers will study the association between cerebral and neurovegetative (sympathetic and parasympathetic) electrophysiological responses in response to a controlled and tolerable pain stimulus, determined for each individual. The pain stimulus will be delivered using an electrically conductive glove used in clinical practice for transcutaneous therapeutic stimulation.
The thresholds of nociception and tolerance will be determined in each healthy volunteer.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Nociceptive intervention arm Receives: Other: Nociceptive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simultaneous scheme of cortical activation and neuro-vegetative responses to controlled nociceptive stimuli
Simultaneous scheme of cortical activation and neuro-vegetative responses secondary to controlled nociceptive stimuli will be defined as the occurrence of at least one among the following:
- Changes of time-frequency distribution of the electroencephalographic activity during phasic or tonic pain stimulation, compared to a prior baseline period.
- Recording of cortical evoked responses during phasic pain stimulation in a time latency range between 100-500 msec.
- Changes in parasympathetic tone measured by Analgesia/Nociception Index (ANI) method (threshold of 50/100) during phasic or tonic stimulation
- Recording of the skin conductance reflex (skin sympathetic response) during phasic or tonic stimulations
Measured: Day 1
Secondary outcomes (9)
EEG time-frequency analysis during phasic pain stimulation
Analysis of time-frequency maps to compare the amplitude in each frequency band during phasic stimulation condition and prior baseline period
Measured: Day 1
Latency of evoked responses to phasic stimulation
Measure of mean latency of evoked responses to phasic stimulation in a time range of 100-500 msec
Measured: Day 1
Pick-to-pick amplitude of evoked responses to phasic stimulation
Measure of mean pick-to-pick amplitude of evoked responses to phasic stimulation in a time range of 100-500 msec
Measured: Day 1
Quantification of skin sympathetic response during phasic stimulation
Mean area under the curve of skin sympathetic response during phasic stimulation compared to the baseline periods before stimulation
Measured: Day 1
Qualitative Change of ANI Value during phasic stimulation
Mean percentage of decrease of ANI value during phasic stimulation compared with the baseline period before stimulation
Measured: Day 1
EEG time-frequency analysis during tonic pain stimulation
Analysis of time-frequency maps to compare the amplitude in each frequency band during tonic stimulation condition and prior baseline period
Measured: Day 1
Quantification of skin sympathetic response during tonic stimulation
Mean area under the curve of skin sympathetic response during tonic stimulation compared to the baseline period before stimulation
Measured: Day 1
Qualitative Change of ANI Value during tonic stimulation
Mean percentage of decrease of ANI value during tonic stimulation compared with the baseline period before stimulation
Measured: Day 1
Selection of dominant configuration of pattern in terms of sensitivity / specificity of the response to different types of nociceptive stimulation
Among the EEG and neurovegetative modifications, investigators will select the dominant association according to the different types of nociceptive stimulation. The dominant association will constitute the pattern of interest. This pattern will be selected if present in more than 80% of subjects. If investigators obtain several patterns of interest associating different cortical or neurovegetative parameters, the final selected pattern will be made up of the smallest number of parameters in order to envisage its transfer in anesthesiological routine
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start6 Apr 2021
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925336
- Sponsor's protocol ID
- 69HCL19_0669
- Acronym
- ALGOBLOC-1
- Status last verified
- Oct 2021
- First submitted
- 22 Jan 2020
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cortical Cerebral Response and Neurovegetative Response to a Nociceptive Stimulus Among Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04925336
- Acronym / sponsor ID
- ALGOBLOC-1 / 69HCL19_0669
- Conditions
- Nociceptive Pain, Anesthesia, Healthy
- Keywords
- Nociceptive stimulation, Healthy volunteer, Simultaneous cortical activation, Neuro-vegetative response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 14 Jun 2021 (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.
Evaluating the intraoperative pain is a major challenge for the anesthesia team. During anesthesia, changes in heart rate and blood pressure are interpreted qualitatively to evaluate the sympathetic response to nociceptive stimulation or the adaptation of analgesia during surgery. The new nociception monitors under development quantitatively explore other variables dependent on sympathetic activity or sympathetic / parasympathetic balance, such as the pulse wave amplitude measurement (Surgical Pleth Index (SPI index)), the pupil dilation reflex, respiratory sinus arrhythmia (ANI, Analgesia Nociception Index), or skin conductance index. Taken independently, these tools provide an assessment of nociception based on variations in the autonomic system, more robust than simply observing heart rate or blood pressure raw values.
However, the relationship between variations in the neurovegetative system and pain can be compromised by various factors or intraoperative events such as hypovolemia, bleeding, certain sympathomimetic or sympatholytic treatments, the hypnosis depth, ventilation variation, fast filling, or body temperature. Moreover, investigators do not know the delay between the application of the painful stimulus and the observation of the variation of the different neurovegetative variables. This constitutes a limit of the practitioners' confidence in these monitoring tools.
The nociception transmission pathways of to the vegetative centers and cortical areas are complex. Investigators hypothesis is that neurovegetative variations in response to nociceptive stimulation are not always associated with a cortical somatosensory response. In this project investigators investigate the relation between cortical (EEG) and vegetative reactions to acute and tonic nociceptive stimuli, as a preliminary step to apply these procedures to assess intraoperative reactions to nociceptive procedures in anesthetized patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Nociceptive stimulationNociceptive intervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteer over 18 years old
- signed informed consent
- affiliated to a social security
Key exclusion criteria (7 listed)
- Chronic pathology requiring chronic treatment
- Cardiac rhythm disorders, pacemaker, cardiotropic treatment
- Taking opioid analgesics during the previous week
- Painful chronic, or migraine
- Pathology of the hand, acrosyndrome, carpal tunnel syndrome
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 |
|---|---|---|
| Nociceptive stimulationThese investigations in healthy volunteers will study the association between cerebral and neurovegetative (sympathetic and parasympathetic) electrophysiological responses in response to a controlled and tolerable pain stimulus, determined for each individual. The pain stimulus will be delivered using an electrically conductive glove used in clinical practice for transcutaneous therapeutic stimulation. The thresholds of nociception and tolerance will be determined in each healthy volunteer. | Other | Experimental |
Primary outcome
Simultaneous scheme of cortical activation and neuro-vegetative responses to controlled nociceptive stimuli
Time frame: Day 1
Simultaneous scheme of cortical activation and neuro-vegetative responses secondary to controlled nociceptive stimuli will be defined as the occurrence of at least one among the following: * Changes of time-frequency distribution of the electroencephalographic activity during phasic or tonic pain stimulation, compared to a prior baseline period. * Recording of cortical evoked responses during phasic pain stimulation in a time latency range between 100-500 msec. * Changes in parasympathetic tone measured by Analgesia/Nociception Index (ANI) method (threshold of 50/100) during phasic or tonic stimulation * Recording of the skin conductance reflex (skin sympathetic response) during phasic or tonic stimulations
9 secondary outcomes
EEG time-frequency analysis during phasic pain stimulation
Time frame: Day 1
Latency of evoked responses to phasic stimulation
Time frame: Day 1
Pick-to-pick amplitude of evoked responses to phasic stimulation
Time frame: Day 1
Quantification of skin sympathetic response during phasic stimulation
Time frame: Day 1
Qualitative Change of ANI Value during phasic stimulation
Time frame: Day 1
EEG time-frequency analysis during tonic pain stimulation
Time frame: Day 1
Quantification of skin sympathetic response during tonic stimulation
Time frame: Day 1
Qualitative Change of ANI Value during tonic stimulation
Time frame: Day 1
Selection of dominant configuration of pattern in terms of sensitivity / specificity of the response to different types of nociceptive stimulation
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- 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 Nociceptive stimulation in people with Nociceptive Pain and Anesthesia, run by Hospices Civils de Lyon at 1 site in France.
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 7 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: finished, as of the sponsor's last update on 15 Oct 2021. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Simultaneous scheme of cortical activation and neuro-vegetative responses to controlled nociceptive stimuli (time frame: Day 1). 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 15 Oct 2021.