Evaluation of Objective Pain Measurement Device

NCT03975660 | Completed Results FDA Device

• 1 other identifier: 51101
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study will attempt to objectively measure pain with an experimental device. The investigators will apply the device to measure patients "pain" due to uterine contractions during routine clinical care to correlate patients verbal pain ratings and analgesia requirements to that measured by the device. A brain oxygenation device, Edwards Foresight, will be used to concurrently to monitor brain oxygenation and hemodynamics, so the relationship between the CereVu ROPA device objective measure of pain and brain oxygenation/hemodynamic changes and patient-reported pain can be determined.

Conditions

Pain; Analgesia; Labor Pain

Outcome Measures

Primary Outcomes (6)

• Average Self-report Pain Score

  Average patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain)

  During labor up to 2 hours after epidural

• Correlation of Average Device Pain Score to Average Self-report Pain Score

  Pearson correlation

  During labor up to 2 hours after epidural

• Correlation Between Pain Score and Brain Oxygenation

  Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and brain oxygenation (0-100%). This outcome will be assessed in part 2 only.

  During labor up to 2 hours after epidural

• Correlation Between Pain Score and Noninvasive Blood Pressure

  Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter noninvasive blood pressure. This outcome will be assessed in part 2 only.

  During labor up to 2 hours after epidural

• Correlation Between Pain Score and Heart Rate

  Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter heart rate. This outcome will be assessed in part 2 only.

  During labor up to 2 hours after epidural

• Correlation Between Pain Score and Pulse Oximetry

  Correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter pulse oximetry (Sp02). This outcome will be assessed in part 2 only.

  During labor up to 2 hours after epidural

Secondary Outcomes (13)

• Time to Reach Pain Score 2 or Less Out of 10

  within 45 minutes after the block placement

• Time Taken for Pain Device Score to be Below Validated Value

  within 45 minutes after the block placement

• Patient Reported Pain Scores After Block

  Up to approximately 45 minutes after the block placement

• Device Recorded Pain Scores After Block

  Up to approximately 45 minutes after the block placement

• Dermatomal Level at 45 Minutes After Block Placement as a Measure of Sensory Blockade Level

  45 minutes

Study Arms (1)

Device Calibration and Validation

EXPERIMENTAL

Patients requesting epidural labor analgesia will have pain levels monitored during labor.

Device: Pain Measurement Device

Interventions

Pain Measurement Device DEVICE

When participants request labor analgesia, the sensors of the pain measurement device (ROPA System \[CereVu Medical, Inc. San Francisco, CA\] and Edwards Foresight device) will be applied to the forehead and connected to the device. Data recording is then started.

Device Calibration and Validation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50
• ASA 1 or 3 +/-E
• Patient requesting epidural labor analgesia
• Good toco tracing (clearly showing contractions at least every 5 minutes)
• Pain score greater than or equal to 3 out of 10 with contractions

You may not qualify if:

• History of chronic pain
• History of chronic opioid use
• BMI \> 45
• Allergy to sensor adhesive material, local anesthetic or opioids
• Contraindication to neuraxial block
• Patient on magnesium infusion
• Inability to give informed consent or understand English

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain; Agnosia; Labor Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Dr. Brendan Carvalho
• Organization: Stanford University School of Medicine

bcarvalho@stanford.edu

(650) 861-8607

Study Officials

• Brendan Carvalho, MBBCh, FRCA

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 5, 2019
• Study Start: November 1, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)