Evaluation of Objective Pain Measurement Device
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1 Device Calibration 50 patients requesting epidural labor analgesia will have pain levels monitored during labor. |
Device: Pain 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.
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| Experimental: Part 2 Device Validation 60 patients requesting epidural labor analgesia will have pain levels monitored during labor. |
Device: Pain 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.
|
Outcome Measures
Primary Outcome Measures
- Average device pain score [During labor up to 2 hours after epidural]
Average pain score obtained by device validated measure (higher scores correspond to more pain)
- 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 between pain score and brain oxygenation [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 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]
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]
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. This outcome will be assessed in part 2 only.
Secondary Outcome Measures
- 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)
- 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 each contraction until 45 min after block [within 45 minutes after the block placement]
Pain score on 0 to 10 scale (higher scores correspond to more pain)
- Device recorded pain scores for each contraction until 45 min after block [within 45 minutes after the block placement]
Device pain score validated measure (higher scores correspond to more pain)
- 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 [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 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-50
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ASA 1 or 3 +/-E
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Patient requesting epidural labor analgesia
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Good toco tracing (clearly showing contractions at least every 5 minutes)
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Pain score greater than or equal to 3 out of 10 with contractions
Exclusion Criteria:
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History of chronic pain
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History of chronic opioid use
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BMI > 45
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Allergy to sensor adhesive material, local anesthetic or opioids
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Contraindication to neuraxial block
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Patient on magnesium infusion
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Inability to give informed consent or understand English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Brendan Carvalho, MBBCh, FRCA, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 51101