Validation of a Nociception Monitor in Healthy Volunteers

Study Overview
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Brief Summary
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Anesthesiology daily practice consists in management of sedation, immobility and analgesia. The monitoring of this last component remains largely based on indirect signs with poor sensitivity and specificity such as heart rate and blood pressure. Accordingly, there is an increased demand for more accurate analgesia monitors. Several parameters have been studied in the recent years such as spectral entropy, skin conductance, pupillometry or heart rate variability (HRV). The HRV is influenced by the balance of sympathetic and parasympathetic tones, and is therefore influenced by pain and analgesia. MDoloris Medical Systems SAS, located in Lille, France, had developed a monitor called PhysioDoloris (TM) that uses an analysis of the HRV to generate a clinically useable index, the Analgesia-Nociception Index (ANI). The ANI varies from 0 to 100, a lower number indicating less parasympathetic tone. It has been shown in previous studies under general anesthesia to decrease at the moment of surgical incision and pneumoperitoneum inflation and to increase with opioids administration. The purpose of this study is to show a correlation between the variation of the ANI with pain scores in awake healthy volunteers who are subjected to standardized painful stimuli of increasing intensity. The investigators hypothesize that an increasing pain score will correlate with decreasing ANI values.

Detailed Description
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See above

Official Title
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Validation of a Nociception Monitor in Healthy Volunteers

Conditions
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Pain

Intervention / Treatment
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* Device: Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers aged 18-80 years old Exclusion Criteria: Heart disease Neurological disease Allergy to cutaneous electrodes Chronic pain and/or chronic analgesics consumption Medication affecting the autonomic nervous system Inability to understand a numeric rating scale (NRS)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation<br>Subjects will receive progressive electrical stimulations with an external nerve stimulator over the ulnar nerve, from 0 mA to 30 mA in increments of 5 (2 Hz single twitch mode), for 3 minutes at each intensity. They will be asked to score their pain level (NRS 0-10) every minute. ANI will be recorded constantly. | Device: Stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ANI index values during increasing intensities of moderately painful electrical stimulation at the forearm level. | The ANI is an index that can vary from 0 (maximum pain) to 100 (no pain) in humans. The primary objective of this study will be to record the ANI values all along the time period of the clinical evaluation, while the subjects are submitted to standardized electrical stimulation going from 0 mA (no stimulation) to a maximum of 25 mA (or less according to the subject tolerance). Each stimulation lasts for 3 minutes. During these 3 minutes the ANI is electronically recorded automatically but the Physiodoloris device. The quantitavive value of the index is then analyzed during each stimulation and for all the stimulations. This will allow to evaluate whether it exists any correlation between the ANI values and the intensity of the electrical stimulation. | Assessed during the entire cycle of stimulation (approx. 30 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ANI correlation with Numerical Rating Scale (NRS) of pain | NRS and ANI absolute values will be recorded all along the study duration (approx. 30min). This will allow to evaluate a likely correlation between the ANI absolute values and the NRS values. | Assessed during the entire cycle of stimulation (approx. 30 min) | 
| Heart rate correlation with ANI | ANI values and HR are recorded for the whole duration of the study. A correlation between these two criteria will be evaluated to know if HR increases (more pain) when ANI decreases (more pain). | Assessed during the entire cycle of stimulation (approx. 30 min) | 
| Blood pressure correlation with ANI |  | Assessed during the entire cycle of stimulation (approx. 30 min) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Monitoring, Analgesia Nociception Index, ANI, PhysioDoloris, Pain