Associations Between Analgesia Nociception Index and Preoperative Anxiety

NCT04875572 | Completed

• 1 other identifier: H19-03148
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety; Opioid Consumption; Cesarean Section

Keywords

Analgesia Nociception Index; Prospective Observational Study

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Pain scores at 48 hours

Secondary Outcomes (5)

• Validation of ANI score for prediction of post-operative opioid requirements at 24 hours

  Opioid use collected during followup at 24 hours

• Validation of ANI score for prediction of post-operative opioid requirements at 48 hours

  Opioid use collected during followup at 48 hours

• Absolute ANI score validation at 24 hours

  Pain score recorded 24 hours post partum

• Absolute ANI score validation at 48 hours

  Pain score recorded at 48 hours post partum

• Percent variability in ANI

  ANI score recorded for 25 minutes perioperatively

Study Arms (1)

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.

Device: Analgesia Nociception Index (ANI) Monitor

Interventions

Analgesia Nociception Index (ANI) Monitor DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Patient receiving an uncomplicated, scheduled caesarean section
• Patient with a normal sinus rhythm

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anton Chau, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

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: Principle Investigator

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: May 6, 2021
• Study Start: February 17, 2021
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

CA (1)