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Completed

NCT Number: NCT03975660

Evaluation of Objective Pain Measurement Device

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.

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Key information

Conditions

Pain Agnosia Analgesia Labor Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Average Self-report Pain Score

    Time frame: During labor up to 2 hours after epidural

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

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

    Time frame: During labor up to 2 hours after epidural

    Pearson correlation

  3. Correlation Between Pain Score and Brain Oxygenation

    Time frame: During labor up to 2 hours after epidural

    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.

  4. Correlation Between Pain Score and Noninvasive Blood Pressure

    Time frame: During labor up to 2 hours after epidural

    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.

  5. Correlation Between Pain Score and Heart Rate

    Time frame: During labor up to 2 hours after epidural

    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.

  6. Correlation Between Pain Score and Pulse Oximetry

    Time frame: During labor up to 2 hours after epidural

    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.

Secondary outcomes

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

    Time frame: within 45 minutes after the block placement

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

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

    Time frame: within 45 minutes after the block placement

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

  3. Patient Reported Pain Scores After Block

    Time frame: Up to approximately 45 minutes after the block placement

    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.

  4. Device Recorded Pain Scores After Block

    Time frame: Up to approximately 45 minutes after the block placement

    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.

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

    Time frame: 45 minutes

  6. Count of Participants With Block Failures

    Time frame: within 45 minutes after the block placement

  7. Count of Participants With Maternal Side Effects

    Time frame: within 45 minutes after the block placement

    Monitored maternal side effects will include nausea, pruritis, hypotension

  8. Count of Participants With Fetal Side Effects

    Time frame: within 45 minutes after the block placement

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

  9. Count of Participants Needing Physician Intervention

    Time frame: within 45 minutes after the block placement

  10. Time From Epidural to Delivery

    Time frame: from epidural to delivery (average approximately 9 hours)

  11. Count of Participants With Normal Vaginal Delivery

    Time frame: from epidural to delivery (expected average: 24 hours)

  12. Count of Participants With Assisted Vaginal Delivery

    Time frame: from epidural to delivery (expected average: 24 hours)

  13. Count of Participants With Cesarean Delivery

    Time frame: from epidural to delivery (expected average: 24 hours)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2019
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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