Trial Outcomes & Findings for Evaluation of Objective Pain Measurement Device (NCT NCT03975660)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

130 participants

Primary outcome timeframe

During labor up to 2 hours after epidural

Results posted on

2025-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	130
Overall Study COMPLETED	130
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participants with skin pigmentation data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device Calibration and Validation n=130 Participants 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.
Age, Continuous	31.3 years STANDARD_DEVIATION 5.35 • n=130 Participants
Sex: Female, Male Female	130 Participants n=130 Participants
Sex: Female, Male Male	0 Participants n=130 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	44 Participants n=130 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=130 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=130 Participants
Race/Ethnicity, Customized Asian	45 Participants n=130 Participants
Race/Ethnicity, Customized Black	2 Participants n=130 Participants
Race/Ethnicity, Customized Caucasian	45 Participants n=130 Participants
Race/Ethnicity, Customized Latin American	6 Participants n=130 Participants
Race/Ethnicity, Customized Native American	1 Participants n=130 Participants
Race/Ethnicity, Customized Unknown/Not Reported	31 Participants n=130 Participants
Region of Enrollment United States	130 Participants n=130 Participants
Skin Pigmentation Fitzpatrick Scale Type I	20 Participants n=127 Participants • Participants with skin pigmentation data
Skin Pigmentation Fitzpatrick Scale Type II	47 Participants n=127 Participants • Participants with skin pigmentation data
Skin Pigmentation Fitzpatrick Scale Type III	26 Participants n=127 Participants • Participants with skin pigmentation data
Skin Pigmentation Fitzpatrick Scale Type IV	30 Participants n=127 Participants • Participants with skin pigmentation data
Skin Pigmentation Fitzpatrick Scale Type V	4 Participants n=127 Participants • Participants with skin pigmentation data
Skin Pigmentation Fitzpatrick Scale Type VI	0 Participants n=127 Participants • Participants with skin pigmentation data
Skin Tone Fair	8 Participants n=129 Participants • Participants with skin tone data
Skin Tone Light	21 Participants n=129 Participants • Participants with skin tone data
Skin Tone Light to Medium	37 Participants n=129 Participants • Participants with skin tone data
Skin Tone Medium	15 Participants n=129 Participants • Participants with skin tone data
Skin Tone Medium to Dark	31 Participants n=129 Participants • Participants with skin tone data
Skin Tone Dark	15 Participants n=129 Participants • Participants with skin tone data
Skin Tone Very Dark	2 Participants n=129 Participants • Participants with skin tone data
Skin Tone Deep	0 Participants n=129 Participants • Participants with skin tone data

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Average Self-report Pain Score	4.08 score on a scale Standard Deviation 3.33

PRIMARY outcome

Timeframe: During labor up to 2 hours after epidural

Pearson correlation

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Correlation of Average Device Pain Score to Average Self-report Pain Score	0.79 correlation coefficient

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Correlation Between Pain Score and Brain Oxygenation	0.05 correlation coefficient

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Correlation Between Pain Score and Noninvasive Blood Pressure Pain score and diastolic blood pressure	0.20 correlation coefficient
Correlation Between Pain Score and Noninvasive Blood Pressure Pain score and systolic blood pressure	0.22 correlation coefficient

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Correlation Between Pain Score and Heart Rate	0.20 correlation coefficient

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Correlation Between Pain Score and Pulse Oximetry	0.05 correlation coefficient

SECONDARY outcome

Timeframe: within 45 minutes after the block placement

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

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Time to Reach Pain Score 2 or Less Out of 10	17.2 minutes Standard Deviation 12.60

SECONDARY outcome

Timeframe: within 45 minutes after the block placement

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

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Time Taken for Pain Device Score to be Below Validated Value	16.6 minutes Standard Deviation 12.22

SECONDARY outcome

Timeframe: Up to approximately 45 minutes after the block placement

Population: Participants with data for the respective time frame

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.

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=125 Participants 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.
Patient Reported Pain Scores After Block Participants with data obtained for ≥ 15 minutes	2.0 score on a scale Standard Deviation 2.50
Patient Reported Pain Scores After Block Participants with data obtained for ≥ 30 minutes	2.0 score on a scale Standard Deviation 2.20
Patient Reported Pain Scores After Block Participants with data obtained for ≥ 45 minutes	1.0 score on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Up to approximately 45 minutes after the block placement

Population: Participants with data recorded within the respective time frame

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.

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=125 Participants 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.
Device Recorded Pain Scores After Block Participants with data recording ≥ 15 minutes	2.9 score on a scale Standard Deviation 1.90
Device Recorded Pain Scores After Block Participants with data recording ≥ 30 minutes	2.7 score on a scale Standard Deviation 1.99
Device Recorded Pain Scores After Block Participants with data recording ≥ 45 minutes	1.5 score on a scale Standard Deviation 1.44

SECONDARY outcome

Timeframe: 45 minutes

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 45 minutes after the block placement

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Count of Participants With Block Failures	18 Participants

SECONDARY outcome

Timeframe: within 45 minutes after the block placement

Monitored maternal side effects will include nausea, pruritis, hypotension

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Count of Participants With Maternal Side Effects	0 Participants

SECONDARY outcome

Timeframe: within 45 minutes after the block placement

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

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Count of Participants With Fetal Side Effects	0 Participants

SECONDARY outcome

Timeframe: within 45 minutes after the block placement

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Count of Participants Needing Physician Intervention	0 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Time From Epidural to Delivery	560 minutes Standard Deviation 398

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Count of Participants With Normal Vaginal Delivery	109 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Count of Participants With Assisted Vaginal Delivery	2 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Device Calibration and Validation n=130 Participants 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.
Count of Participants With Cesarean Delivery	19 Participants

Adverse Events

Device Calibration and Validation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brendan Carvalho

Stanford University School of Medicine

Phone: (650) 861-8607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place