Analgesia, Labor Pain, Pain
Conditions
Brief 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.
Interventions
DEVICEPain 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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Self-report Pain Score | 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) |
| Correlation of Average Device Pain Score to Average Self-report Pain Score | During labor up to 2 hours after epidural | Pearson correlation |
| Correlation Between Pain Score and Brain Oxygenation | 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. |
| Correlation Between Pain Score and Noninvasive Blood Pressure | 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. |
| Correlation Between Pain Score and Heart Rate | 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. |
| Correlation Between Pain Score and Pulse Oximetry | 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
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Maternal Side Effects | within 45 minutes after the block placement | Monitored maternal side effects will include nausea, pruritis, hypotension |
| Count of Participants With Fetal Side Effects | within 45 minutes after the block placement | Monitored fetal side effects include fetal decelerations early/variable/late |
| Count of Participants Needing Physician Intervention | within 45 minutes after the block placement | — |
| Time to Reach Pain Score 2 or Less Out of 10 | within 45 minutes after the block placement | Pain score on 0 to 10 scale (higher scores correspond to more pain) |
| 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) | — |
| Time From Epidural to Delivery | from epidural to delivery (average approximately 9 hours) | — |
| Time Taken for Pain Device Score to be Below Validated Value | within 45 minutes after the block placement | Validated value is from the validated reading recorded by the sensor in the pilot study |
| Patient Reported Pain Scores After Block | 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. |
| Device Recorded Pain Scores After Block | 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. |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 130 |
| Total | 130 |
Baseline characteristics
| Characteristic | Device Calibration and Validation |
|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 5.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized Asian | 45 Participants |
| Race/Ethnicity, Customized Black | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 45 Participants |
| Race/Ethnicity, Customized Latin American | 6 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants |
| Race/Ethnicity, Customized Unknown/Not Reported | 31 Participants |
| Region of Enrollment United States | 130 Participants |
| Sex: Female, Male Female | 130 Participants |
| Sex: Female, Male Male | 0 Participants |
| Skin Pigmentation Fitzpatrick Scale Type I | 20 Participants |
| Skin Pigmentation Fitzpatrick Scale Type II | 47 Participants |
| Skin Pigmentation Fitzpatrick Scale Type III | 26 Participants |
| Skin Pigmentation Fitzpatrick Scale Type IV | 30 Participants |
| Skin Pigmentation Fitzpatrick Scale Type V | 4 Participants |
| Skin Pigmentation Fitzpatrick Scale Type VI | 0 Participants |
| Skin Tone Dark | 15 Participants |
| Skin Tone Deep | 0 Participants |
| Skin Tone Fair | 8 Participants |
| Skin Tone Light | 21 Participants |
| Skin Tone Light to Medium | 37 Participants |
| Skin Tone Medium | 15 Participants |
| Skin Tone Medium to Dark | 31 Participants |
| Skin Tone Very Dark | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 130 |
| other Total, other adverse events | 0 / 130 |
| serious Total, serious adverse events | 0 / 130 |
Outcome results
Primary
Average Self-report Pain Score
Average patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain)
Time frame: During labor up to 2 hours after epidural
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Calibration and Validation | Average Self-report Pain Score | 4.08 score on a scale | Standard Deviation 3.33 |
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.
Time frame: During labor up to 2 hours after epidural
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Calibration and Validation | Correlation Between Pain Score and Brain Oxygenation | 0.05 correlation coefficient |
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.
Time frame: During labor up to 2 hours after epidural
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Calibration and Validation | Correlation Between Pain Score and Heart Rate | 0.20 correlation coefficient |
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.
Time frame: During labor up to 2 hours after epidural
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device Calibration and Validation | Correlation Between Pain Score and Noninvasive Blood Pressure | Pain score and diastolic blood pressure | 0.20 correlation coefficient |
| Device Calibration and Validation | Correlation Between Pain Score and Noninvasive Blood Pressure | Pain score and systolic blood pressure | 0.22 correlation coefficient |
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.
Time frame: During labor up to 2 hours after epidural
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Calibration and Validation | Correlation Between Pain Score and Pulse Oximetry | 0.05 correlation coefficient |
Primary
Correlation of Average Device Pain Score to Average Self-report Pain Score
Pearson correlation
Time frame: During labor up to 2 hours after epidural
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Calibration and Validation | Correlation of Average Device Pain Score to Average Self-report Pain Score | 0.79 correlation coefficient |
Secondary
Count of Participants Needing Physician Intervention
Time frame: within 45 minutes after the block placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Calibration and Validation | Count of Participants Needing Physician Intervention | 0 Participants |
Secondary
Count of Participants With Assisted Vaginal Delivery
Time frame: from epidural to delivery (expected average: 24 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Calibration and Validation | Count of Participants With Assisted Vaginal Delivery | 2 Participants |
Secondary
Count of Participants With Block Failures
Time frame: within 45 minutes after the block placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Calibration and Validation | Count of Participants With Block Failures | 18 Participants |
Secondary
Count of Participants With Cesarean Delivery
Time frame: from epidural to delivery (expected average: 24 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Calibration and Validation | Count of Participants With Cesarean Delivery | 19 Participants |
Secondary
Count of Participants With Fetal Side Effects
Monitored fetal side effects include fetal decelerations early/variable/late
Time frame: within 45 minutes after the block placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Calibration and Validation | Count of Participants With Fetal Side Effects | 0 Participants |
Secondary
Count of Participants With Maternal Side Effects
Monitored maternal side effects will include nausea, pruritis, hypotension
Time frame: within 45 minutes after the block placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Calibration and Validation | Count of Participants With Maternal Side Effects | 0 Participants |
Secondary
Count of Participants With Normal Vaginal Delivery
Time frame: from epidural to delivery (expected average: 24 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Calibration and Validation | Count of Participants With Normal Vaginal Delivery | 109 Participants |
Secondary
Dermatomal Level at 45 Minutes After Block Placement as a Measure of Sensory Blockade Level
Time frame: 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.
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.
Time frame: Up to approximately 45 minutes after the block placement
Population: Participants with data recorded within the respective time frame
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Calibration and Validation | Device Recorded Pain Scores After Block | Participants with data recording ≥ 15 minutes | 2.9 score on a scale | Standard Deviation 1.9 |
| Device Calibration and Validation | Device Recorded Pain Scores After Block | Participants with data recording ≥ 30 minutes | 2.7 score on a scale | Standard Deviation 1.99 |
| Device Calibration and Validation | Device Recorded Pain Scores After Block | Participants with data recording ≥ 45 minutes | 1.5 score on a scale | Standard Deviation 1.44 |
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.
Time frame: Up to approximately 45 minutes after the block placement
Population: Participants with data for the respective time frame
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Calibration and Validation | Patient Reported Pain Scores After Block | Participants with data obtained for ≥ 15 minutes | 2.0 score on a scale | Standard Deviation 2.5 |
| Device Calibration and Validation | Patient Reported Pain Scores After Block | Participants with data obtained for ≥ 30 minutes | 2.0 score on a scale | Standard Deviation 2.2 |
| Device Calibration and Validation | Patient Reported Pain Scores After Block | Participants with data obtained for ≥ 45 minutes | 1.0 score on a scale | Standard Deviation 1.4 |
Secondary
Time From Epidural to Delivery
Time frame: from epidural to delivery (average approximately 9 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Calibration and Validation | Time From Epidural to Delivery | 560 minutes | Standard Deviation 398 |
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
Time frame: within 45 minutes after the block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Calibration and Validation | Time Taken for Pain Device Score to be Below Validated Value | 16.6 minutes | Standard Deviation 12.22 |
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)
Time frame: within 45 minutes after the block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Calibration and Validation | Time to Reach Pain Score 2 or Less Out of 10 | 17.2 minutes | Standard Deviation 12.6 |