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PainNCT03975660

Evaluation of Objective Pain Measurement Device

A study testing Pain Measurement Device in people with Pain and Analgesia, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Pain, Analgesia, Labor Pain
What is being tested?
Pain Measurement Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteUnited States
Study dates
1 Nov 2019to 31 Oct 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

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.

Read the 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.

Being tested
Pain Measurement Device
Medical subject headings
Pain, Agnosia, Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Measurement DeviceDevice

    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.

Study groups in NCT03975660
Study groupRoleWhat they receive
Device Calibration and ValidationExperimentalPatients requesting epidural labor analgesia will have pain levels monitored during labor.
Receives: Device: Pain Measurement Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Self-report Pain Score

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

    Measured: During labor up to 2 hours after epidural

  2. Correlation of Average Device Pain Score to Average Self-report Pain Score

    Pearson correlation

    Measured: During labor up to 2 hours after epidural

  3. 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.

    Measured: During labor up to 2 hours after epidural

  4. 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.

    Measured: During labor up to 2 hours after epidural

  5. 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.

    Measured: During labor up to 2 hours after epidural

  6. 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.

    Measured: During labor up to 2 hours after epidural

Secondary outcomes (13)

  1. Time to Reach Pain Score 2 or Less Out of 10

    Pain score on 0 to 10 scale (higher scores correspond to more pain)

    Measured: within 45 minutes after the block placement

  2. Time Taken for Pain Device Score to be Below Validated Value

    Validated value is from the validated reading recorded by the sensor in the pilot study

    Measured: within 45 minutes after the block placement

  3. Patient Reported Pain Scores After Block

    Pain score on 0 to 10 scale (higher scores correspond to more pain). Pain scores were obtained at random intervals and the scores were summed and averaged to create the reported score. Patients stopped rating pain once the level dropped to zero.

    Measured: Up to approximately 45 minutes after the block placement

  4. Device Recorded Pain Scores After Block

    Device pain score validated measure (range: 0 to 10, higher scores correspond to more pain). Pain scores were obtained at random intervals and the scores were summed and averaged to create the reported score. Device recording was discontinued when pain level dropped to zero.

    Measured: Up to approximately 45 minutes after the block placement

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

    Measured: 45 minutes

  6. Count of Participants With Block Failures

    Measured: within 45 minutes after the block placement

  7. Count of Participants With Maternal Side Effects

    Monitored maternal side effects will include nausea, pruritis, hypotension

    Measured: within 45 minutes after the block placement

  8. Count of Participants With Fetal Side Effects

    Monitored fetal side effects include fetal decelerations early/variable/late

    Measured: within 45 minutes after the block placement

  9. Count of Participants Needing Physician Intervention

    Measured: within 45 minutes after the block placement

  10. Time From Epidural to Delivery

    Measured: from epidural to delivery (average approximately 9 hours)

  11. Count of Participants With Normal Vaginal Delivery

    Measured: from epidural to delivery (expected average: 24 hours)

  12. Count of Participants With Assisted Vaginal Delivery

    Measured: from epidural to delivery (expected average: 24 hours)

  13. Count of Participants With Cesarean Delivery

    Measured: from epidural to delivery (expected average: 24 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2019
  2. Study start1 Nov 2019
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Resources

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
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03975660
Sponsor's protocol ID
51101
Status last verified
Jun 2025
First submitted
1 Jun 2019
Last updated
8 Jun 2025
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pain Measurement Device in people with Pain and Analgesia, run by Stanford University at 1 site in United States.

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 5 inclusion and 7 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 8 Jun 2025. 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 United States. 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?

Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Average Self-report Pain Score (time frame: During labor up to 2 hours after epidural). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03975660.

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 8 Jun 2025.

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