NCT03975660

Evaluation of Objective Pain Measurement Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Despite all the progress in our understanding of the basic mechanisms of pain, the gold standard for measuring pain is still a subjective verbal numeric rating scale rating (0-10) obtained from the individual reporting pain. This method is not objective and cannot be used in all patient populations. This study will attempt to objectively measure pain in laboring mothers with a pain measurement device. The investigators aim to 1) see if the pain measurement device (CereVu ROPA) is capable of reflecting different levels of pain ratings in patients in labor having uterine contractions and then changes in pain after receiving different neuraxial techniques for labor pain and to 2) additionally determine the relationship between the CereVu ROPA device, brain oxygenation/hemodynamic changes and patient-reported pain scores.

Conditions

• Pain
• Analgesia
• Labor Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2019-06-05
• Last updated: 2025-06-08
• Results posted: 2025-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study