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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
130
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.
Stanford University
Stanford, California, United States
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
Correlation of Average Device Pain Score to Average Self-report Pain Score
Pearson correlation
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During labor up to 2 hours after epidural
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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
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
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
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
Dermatomal Level at 45 Minutes After Block Placement as a Measure of Sensory Blockade Level
Time frame: 45 minutes
Count of Participants With Block Failures
Time frame: within 45 minutes after the block placement
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
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
Count of Participants Needing Physician Intervention
Time frame: within 45 minutes after the block placement
Time From Epidural to Delivery
Time frame: from epidural to delivery (average approximately 9 hours)
Count of Participants With Normal Vaginal Delivery
Time frame: from epidural to delivery (expected average: 24 hours)
Count of Participants With Assisted Vaginal Delivery
Time frame: from epidural to delivery (expected average: 24 hours)
Count of Participants With Cesarean Delivery
Time frame: from epidural to delivery (expected average: 24 hours)