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Evaluation of Objective Pain Measurement Device

NCT03975660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-06-08

Study results available
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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

Interventions

DEVICE

Pain Measurement 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.

Sponsors & Collaborators

Principal Investigators

  • Brendan Carvalho, MBBCh, FRCA · Stanford University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03975660 on ClinicalTrials.gov