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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Calibration and Validation | Experimental | Patients requesting epidural labor analgesia will have pain levels monitored during labor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Pain Score 2 or Less Out of 10 | Pain score on 0 to 10 scale (higher scores correspond to more pain) | within 45 minutes after the block placement |
| Time Taken for Pain Device Score to be Below Validated Value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brendan Carvalho, MBBCh, FRCA | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device Calibration and Validation | When participants request labor analgesia, the sensors of the pain measurement device (ROPA System [CereVu Medical, Inc. San Francisco, CA] and Edwards Foresight device) are applied to the forehead and connected to the device. Data recording is then started. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Device Calibration and Validation | When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Self-report Pain Score | Average patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) | Posted | Mean | Standard Deviation | score on a scale | During labor up to 2 hours after epidural |
|
|
1 day (average approximately 2 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Calibration and Validation | When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brendan Carvalho | Stanford University School of Medicine | (650) 861-8607 | bcarvalho@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 4, 2022 | Oct 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2024 | Oct 31, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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|
| During labor up to 2 hours after epidural |
Validated value is from the validated reading recorded by the sensor in the pilot study
| within 45 minutes after the block placement |
| 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. | Up to approximately 45 minutes after the block placement |
| 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. | 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 |
| Count of Participants With Block Failures | within 45 minutes after the block placement |
| Count of Participants With Maternal Side Effects | Monitored maternal side effects will include nausea, pruritis, hypotension | within 45 minutes after the block placement |
| Count of Participants With Fetal Side Effects | Monitored fetal side effects include fetal decelerations early/variable/late | within 45 minutes after the block placement |
| Count of Participants Needing Physician Intervention | within 45 minutes after the block placement |
| Time From Epidural to Delivery | from epidural to delivery (average approximately 9 hours) |
| Count of Participants With Normal Vaginal Delivery | from epidural to delivery (expected average: 24 hours) |
| Count of Participants With Assisted Vaginal Delivery | from epidural to delivery (expected average: 24 hours) |
| Count of Participants With Cesarean Delivery | from epidural to delivery (expected average: 24 hours) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Skin Pigmentation Fitzpatrick Scale | Type I: always burns, never tans (palest; freckles) Type II: usually burns, tans minimally (light colored but darker than pale) Type III: sometimes mild burn, tans uniformly (golden honey or olive) Type IV: burns minimally, always tans well (moderate brown) Type V: very rarely burns, tans very easily (dark brown) Type VI: never burns (deeply pigmented dark brown to darkest brown) | Participants with skin pigmentation data | Count of Participants | Participants |
|
| Skin Tone | Participants with skin tone data | Count of Participants | Participants |
|
|
| Primary | Correlation of Average Device Pain Score to Average Self-report Pain Score | Pearson correlation | Posted | Number | correlation coefficient | During labor up to 2 hours after epidural |
|
|
|
| Primary | 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. | Posted | Number | correlation coefficient | During labor up to 2 hours after epidural |
|
|
|
| Primary | 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. | Posted | Number | correlation coefficient | During labor up to 2 hours after epidural |
|
|
|
| Primary | 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. | Posted | Number | correlation coefficient | During labor up to 2 hours after epidural |
|
|
|
| Primary | 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. | Posted | Number | correlation coefficient | During labor up to 2 hours after epidural |
|
|
|
| Secondary | Time to Reach Pain Score 2 or Less Out of 10 | Pain score on 0 to 10 scale (higher scores correspond to more pain) | Posted | Mean | Standard Deviation | minutes | within 45 minutes after the block placement |
|
|
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| Secondary | 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 | Posted | Mean | Standard Deviation | minutes | within 45 minutes after the block placement |
|
|
|
| Secondary | 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. | Participants with data for the respective time frame | Posted | Mean | Standard Deviation | score on a scale | Up to approximately 45 minutes after the block placement |
|
|
|
| Secondary | 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. | Participants with data recorded within the respective time frame | Posted | Mean | Standard Deviation | score on a scale | Up to approximately 45 minutes after the block placement |
|
|
|
| Secondary | Dermatomal Level at 45 Minutes After Block Placement as a Measure of Sensory Blockade Level | Dermatomal testing was not performed to reduce burden on participants. The study team decided it was not critical prior to the start of the study, however, the study protocol was not amended to reflect this change. No data were collected for this Outcome Measure. | Posted | 45 minutes |
|
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| Secondary | Count of Participants With Block Failures | Posted | Count of Participants | Participants | within 45 minutes after the block placement |
|
|
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| Secondary | Count of Participants With Maternal Side Effects | Monitored maternal side effects will include nausea, pruritis, hypotension | Posted | Count of Participants | Participants | within 45 minutes after the block placement |
|
|
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| Secondary | Count of Participants With Fetal Side Effects | Monitored fetal side effects include fetal decelerations early/variable/late | Posted | Count of Participants | Participants | within 45 minutes after the block placement |
|
|
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| Secondary | Count of Participants Needing Physician Intervention | Posted | Count of Participants | Participants | within 45 minutes after the block placement |
|
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| Secondary | Time From Epidural to Delivery | Posted | Mean | Standard Deviation | minutes | from epidural to delivery (average approximately 9 hours) |
|
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| Secondary | Count of Participants With Normal Vaginal Delivery | Posted | Count of Participants | Participants | from epidural to delivery (expected average: 24 hours) |
|
|
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| Secondary | Count of Participants With Assisted Vaginal Delivery | Posted | Count of Participants | Participants | from epidural to delivery (expected average: 24 hours) |
|
|
|
| Secondary | Count of Participants With Cesarean Delivery | Posted | Count of Participants | Participants | from epidural to delivery (expected average: 24 hours) |
|
|
|
| 0 |
| 130 |
| 0 |
| 130 |
| 0 |
| 130 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
|
| Participants with data obtained for ≥ 45 minutes |
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| Participants with data recording ≥ 45 minutes |
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