Evaluation of Objective Pain Measurement Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Objective Pain Measurement Device

Conditions
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Pain, Analgesia, Labor Pain

Intervention / Treatment
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* Device: Pain Measurement Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 Device Calibration<br>50 patients requesting epidural labor analgesia will have pain levels monitored during labor. | Device: Pain Measurement Device<br>* 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.<br>|
| Experimental: Part 2 Device Validation<br>60 patients requesting epidural labor analgesia will have pain levels monitored during labor. | Device: Pain Measurement Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average device pain score | Average pain score obtained by device validated measure (higher scores correspond to more pain) | During labor up to 2 hours after epidural | 
| 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 between pain score and brain oxygenation | 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 | 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 | 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. This outcome will be assessed in part 2 only. | During labor up to 2 hours after epidural | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 each contraction until 45 min after block | Pain score on 0 to 10 scale (higher scores correspond to more pain) | within 45 minutes after the block placement | 
| Device recorded pain scores for each contraction until 45 min after block | Device pain score validated measure (higher scores correspond to more pain) | within 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 need Physician intervention |  | within 45 minutes after the block placement | 
| Time from epidural to delivery |  | from epidural to delivery (expected average: 24 hours) | 
| Counts of normal vaginal delivery |  | from epidural to delivery (expected average: 24 hours) | 
| Counts of assisted vaginal delivery |  | from epidural to delivery (expected average: 24 hours) | 
| Counts of Cesarean delivery |  | from epidural to delivery (expected average: 24 hours) |