AnxietyPANICNCT04875572
Associations Between Analgesia Nociception Index and Preoperative Anxiety
A study testing Analgesia Nociception Index (ANI) Monitor in people with Anxiety and Opioid Consumption, run by University of British Columbia at 1 site in Canada.
Trial summary
The management and prediction of pain is one of the most crucial jobs for anesthetists. It has been shown that a patient's ability to remain calm during stressful situations is related to their post-surgical pain scores. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Opioid Consumption, Cesarean Section
- What is being tested?
- Analgesia Nociception Index (ANI) Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 17 Feb 2021to 27 Sep 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years of age or older.
- Patient receiving an uncomplicated, scheduled caesarean section
- Patient with a normal sinus rhythm
Who cannot join
- Presentation with cardiac arrhythmia
- Contraindications to neuraxial analgesia (ex. patient refusal, infection at the site of injection, uncorrected hypovolemia, allergy, increased intracranial pressure, coagulopathy, sepsis, fixed cardiac output states, or indeterminate neurological status), or risk factors likely to affect placement or function of the spinal needle (ex. previous back surgery, significant uncorrected scoliosis, or morbid obesity (BMI >40))
- History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
- Current or historical evidence of any significant medical conditions, including diseases of pregnancy
- Clinical settings in which general anesthesia may be preferable (ex. patient with failed regional anesthetic, patient with history of bleeding, fetal shoulder dystocia etc.)
- Anticipated fetal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Analgesia Nociceptive Index With Preoperative Anxiety: A Prospective Observational Study
The management and prediction of pain is one of the most crucial jobs for anesthetists. It has been shown that a patient's ability to remain calm during stressful situations is related to their post-surgical pain scores. The MetroDoloris Analgesia Nociception Index (ANI) monitor is a heart-rate monitor that provides us with a number which reflects a patient's state of relaxation (or parasympathetic tone). For this reason, the investigators are testing whether ANI can be used as a metric for perioperative anxiety, and a predictive tool for pain after c-sections.
Read the detailed description
Purpose: The purpose of the study is to evaluate the MDoloris ANI monitor as an effective tool for objectively measuring perioperative stress, and as a prediction of post-operative pain.
Hypothesis: High perioperative anxiety scores, high post-operative pain scores, high post-operative anesthetic dosing, and high incidence of provider intervention will be positively correlated with frequency and magnitude of changes in the ANI score.
Justification: Anesthetists are constantly monitoring a patient's heart rate during caesarean sections. This is standard care, and this monitoring provides useful information about a patient's level of sedation, analgesia, and comfort. The ANI monitor takes more heart rate information through two electrodes placed on a patient's chest, and non-invasively provides more information by which anesthetists can improve the patient's standard of care.
Primary Objective: To determine whether the ANI monitor is a viable means of measuring perioperative anxiety during C-sections.
Secondary Objectives:
To determine if the ANI monitor is capable of providing anesthetists with an objective prediction variable for post-operative pain.
Research Methods and Design: Once eligibility is determined , the patient will be approached in the pre-operative waiting area at a time determined by the charge nurse. If they consent to the study, they will be given an validated questionnaire which assesses the patient's level of operative stress. After the survey, they will have the ANI electrodes placed on their chest by a member of the study team. The collection of this pre-surgical data provides the research team with a baseline to which they will compare the operative and post-operative results. Five to ten minutes prior to their surgery, the electrodes will be removed, and the monitor will be brought to the OR. The monitor will be plugged in to an electrical socket far away from areas of high traffic, and will not disturb the flow of OR staff.
During the operation, a member of the study team will constantly watch the ANI monitor to check for optimal connectivity, and will record the events of surgery. A record of the events is critical to interpreting the meaning of the ANI score, as it allows the team to match distinct stimuli with the number produced by the monitor.
The spinal block typically wears off after 24 hours, so at 24- and 48 hours following the c-section, a study team member will approach the patient on the wards, and ask for their resting, and evoked pain scores on a VAS 0-100 mm scale. Evoked pain is pain caused by movement. The investigators have chosen the previously used metric of a change in position: from lying to sitting. If the patient has received drugs for pain already, the investigator will ask them to score the pain they experienced before receiving medication. The study investigator will finally record the provider-administered dose of pain medication from the patient's chart.
- Conditions
- Anxiety, Opioid Consumption, Cesarean Section
- Being tested
- Analgesia Nociception Index (ANI) Monitor
- Keywords
- Analgesia Nociception Index, Prospective Observational Study
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia Nociception Index (ANI) MonitorDevice
The ANI monitor produces an objective measure of parasympathetic tone through non-invasive electrodes placed on the patient's chest. The patient's standard of care is not affected, and the anesthetist is blinded to the monitor, so as not to affect their anesthetic practice.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Since this is a single group study, all patients enrolled will receive the same care, as described in the study description above. Receives: Device: Analgesia Nociception Index (ANI) Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of Analgesia Nociception Index (ANI) score for objective measurement of anxiety
Association between frequency and magnitude of changes in ANI during the perioperative time period with patient's reported perioperative anxiety scores
Measured: 25 minutes perioperatively
Validation of ANI score for prediction of post-operative pain 24 hours
Association between frequency and magnitude of changes in the ANI with patient's reported VAS evoked and resting pain scores at 24h and 48h. Evoked pain is defined as pain experienced from moving from a supine position (where resting pain VAS is measured) to seated position.
Measured: Pain scores at 24 hours
Validation of ANI score for prediction of post-operative pain 48 hours
Association between frequency and magnitude of changes in the ANI with patient's reported VAS evoked and resting pain scores at 24h and 48h. Evoked pain is defined as pain experienced from moving from a supine position (where resting pain VAS is measured) to seated position.
Measured: Pain scores at 48 hours
Secondary outcomes (5)
Validation of ANI score for prediction of post-operative opioid requirements at 24 hours
Association between frequency and magnitude of changes in the ANI with patient's total opioid consumption in oral morphine equivalents at 24h and 48h
Measured: Opioid use collected during followup at 24 hours
Validation of ANI score for prediction of post-operative opioid requirements at 48 hours
Association between frequency and magnitude of changes in the ANI with patient's total opioid consumption in oral morphine equivalents at 24h and 48h
Measured: Opioid use collected during followup at 48 hours
Absolute ANI score validation at 24 hours
Determining whether post-partum pain, and operative anxiety are correlated with frequency of absolute ANI score less than 50
Measured: Pain score recorded 24 hours post partum
Absolute ANI score validation at 48 hours
Determining whether post-partum pain, and operative anxiety are correlated with frequency of absolute ANI score less than 50
Measured: Pain score recorded at 48 hours post partum
Percent variability in ANI
Use of Percent Variability (PV) statistic as a measure of top-down regulation of parasympathetic tone
Measured: ANI score recorded for 25 minutes perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start17 Feb 2021
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Chau, University of British Columbia
- Investigators
- Anton Chau, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875572
- Sponsor's protocol ID
- H19-03148
- Acronym
- PANIC
- Status last verified
- Sep 2021
- First submitted
- 23 Feb 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Analgesia Nociceptive Index With Preoperative Anxiety: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04875572
- Acronym / sponsor ID
- PANIC / H19-03148
- Conditions
- Anxiety, Opioid Consumption, Cesarean Section
- Keywords
- Analgesia Nociception Index, Prospective Observational Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 6 May 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.
The management and prediction of pain is one of the most crucial jobs for anesthetists. It has been shown that a patient's ability to remain calm during stressful situations is related to their post-surgical pain scores. The MetroDoloris Analgesia Nociception Index (ANI) monitor is a heart-rate monitor that provides us with a number which reflects a patient's state of relaxation (or parasympathetic tone). For this reason, the investigators are testing whether ANI can be used as a metric for perioperative anxiety, and a predictive tool for pain after c-sections.
Detailed description
Purpose: The purpose of the study is to evaluate the MDoloris ANI monitor as an effective tool for objectively measuring perioperative stress, and as a prediction of post-operative pain.
Hypothesis: High perioperative anxiety scores, high post-operative pain scores, high post-operative anesthetic dosing, and high incidence of provider intervention will be positively correlated with frequency and magnitude of changes in the ANI score.
Justification: Anesthetists are constantly monitoring a patient's heart rate during caesarean sections. This is standard care, and this monitoring provides useful information about a patient's level of sedation, analgesia, and comfort. The ANI monitor takes more heart rate information through two electrodes placed on a patient's chest, and non-invasively provides more information by which anesthetists can improve the patient's standard of care.
Primary Objective: To determine whether the ANI monitor is a viable means of measuring perioperative anxiety during C-sections.
Secondary Objectives:
To determine if the ANI monitor is capable of providing anesthetists with an objective prediction variable for post-operative pain.
Research Methods and Design: Once eligibility is determined , the patient will be approached in the pre-operative waiting area at a time determined by the charge nurse. If they consent to the study, they will be given an validated questionnaire which assesses the patient's level of operative stress. After the survey, they will have the ANI electrodes placed on their chest by a member of the study team. The collection of this pre-surgical data provides the research team with a baseline to which they will compare the operative and post-operative results. Five to ten minutes prior to their surgery, the electrodes will be removed, and the monitor will be brought to the OR. The monitor will be plugged in to an electrical socket far away from areas of high traffic, and will not disturb the flow of OR staff.
During the operation, a member of the study team will constantly watch the ANI monitor to check for optimal connectivity, and will record the events of surgery. A record of the events is critical to interpreting the meaning of the ANI score, as it allows the team to match distinct stimuli with the number produced by the monitor.
The spinal block typically wears off after 24 hours, so at 24- and 48 hours following the c-section, a study team member will approach the patient on the wards, and ask for their resting, and evoked pain scores on a VAS 0-100 mm scale. Evoked pain is pain caused by movement. The investigators have chosen the previously used metric of a change in position: from lying to sitting. If the patient has received drugs for pain already, the investigator will ask them to score the pain they experienced before receiving medication. The study investigator will finally record the provider-administered dose of pain medication from the patient's chart.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Analgesia Nociception Index (ANI) MonitorSince this is a single group study, all patients enrolled will receive the same care, as described in the study description above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 years of age or older.
- Patient receiving an uncomplicated, scheduled caesarean section
- Patient with a normal sinus rhythm
Key exclusion criteria (6 listed)
- Presentation with cardiac arrhythmia
- Contraindications to neuraxial analgesia (ex. patient refusal, infection at the site of injection, uncorrected hypovolemia, allergy, increased intracranial pressure, coagulopathy, sepsis, fixed cardiac output states, or indeterminate neurological status), or risk factors likely to affect placement or function of the spinal needle (ex. previous back surgery, significant uncorrected scoliosis, or morbid obesity (BMI >40))
- History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
- Current or historical evidence of any significant medical conditions, including diseases of pregnancy
- Clinical settings in which general anesthesia may be preferable (ex. patient with failed regional anesthetic, patient with history of bleeding, fetal shoulder dystocia etc.)
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 |
|---|---|---|
| Analgesia Nociception Index (ANI) MonitorThe ANI monitor produces an objective measure of parasympathetic tone through non-invasive electrodes placed on the patient's chest. The patient's standard of care is not affected, and the anesthetist is blinded to the monitor, so as not to affect their anesthetic practice. | Device | Study group |
Primary outcome
Validation of Analgesia Nociception Index (ANI) score for objective measurement of anxiety
Time frame: 25 minutes perioperatively
Association between frequency and magnitude of changes in ANI during the perioperative time period with patient's reported perioperative anxiety scores
Validation of ANI score for prediction of post-operative pain 24 hours
Time frame: Pain scores at 24 hours
Association between frequency and magnitude of changes in the ANI with patient's reported VAS evoked and resting pain scores at 24h and 48h. Evoked pain is defined as pain experienced from moving from a supine position (where resting pain VAS is measured) to seated position.
Validation of ANI score for prediction of post-operative pain 48 hours
Time frame: Pain scores at 48 hours
Association between frequency and magnitude of changes in the ANI with patient's reported VAS evoked and resting pain scores at 24h and 48h. Evoked pain is defined as pain experienced from moving from a supine position (where resting pain VAS is measured) to seated position.
5 secondary outcomes
Validation of ANI score for prediction of post-operative opioid requirements at 24 hours
Time frame: Opioid use collected during followup at 24 hours
Validation of ANI score for prediction of post-operative opioid requirements at 48 hours
Time frame: Opioid use collected during followup at 48 hours
Absolute ANI score validation at 24 hours
Time frame: Pain score recorded 24 hours post partum
Absolute ANI score validation at 48 hours
Time frame: Pain score recorded at 48 hours post partum
Percent variability in ANI
Time frame: ANI score recorded for 25 minutes perioperatively
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 1 Oct 2021.
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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.
Anton Chau, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesia Nociception Index (ANI) Monitor in people with Anxiety and Opioid Consumption, run by University of British Columbia 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 6 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 1 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 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 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?
Validation of Analgesia Nociception Index (ANI) score for objective measurement of anxiety (time frame: 25 minutes perioperatively). The study lists 3 primary outcomes in all. 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 1 Oct 2021.