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Evaluation of Objective Pain Measurement Device

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ClinicalTrials.gov Identifier: NCT03975660
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University

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
Pain Analgesia Labor Pain Device: Pain Measurement Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Objective Pain Measurement Device
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

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.

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.




Primary Outcome Measures :
  1. Average device pain score [ Time Frame: During labor up to 2 hours after epidural ]
    Average pain score obtained by device validated measure (higher scores correspond to more pain)

  2. Average self-report pain score [ Time Frame: 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)

  3. Correlation between pain score and brain oxygenation [ Time Frame: 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.

  4. Correlation between pain score and noninvasive blood pressure [ Time Frame: 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.

  5. Correlation between pain score and heart rate [ Time Frame: 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.

  6. Correlation between pain score and pulse oximetry [ Time Frame: 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 :
  1. Time to reach pain score 2 or less out of 10 [ Time Frame: within 45 minutes after the block placement ]
    Pain score on 0 to 10 scale (higher scores correspond to more pain)

  2. Time taken for pain device score to be below validated value [ Time Frame: within 45 minutes after the block placement ]
    Validated value is from the validated reading recorded by the sensor in the pilot study

  3. Patient reported pain scores after each contraction until 45 min after block [ Time Frame: within 45 minutes after the block placement ]
    Pain score on 0 to 10 scale (higher scores correspond to more pain)

  4. Device recorded pain scores for each contraction until 45 min after block [ Time Frame: within 45 minutes after the block placement ]
    Device pain score validated measure (higher scores correspond to more pain)

  5. Dermatomal level at 45 minutes after block placement as a measure of sensory blockade level [ Time Frame: 45 minutes ]
  6. Count of participants with block failures [ Time Frame: within 45 minutes after the block placement ]
  7. Count of participants with maternal side effects [ Time Frame: within 45 minutes after the block placement ]
    Monitored maternal side effects will include nausea, pruritis, hypotension

  8. Count of participants with fetal side effects [ Time Frame: within 45 minutes after the block placement ]
    Monitored fetal side effects include fetal decelerations early/variable/late

  9. Count of participants need Physician intervention [ Time Frame: within 45 minutes after the block placement ]
  10. Time from epidural to delivery [ Time Frame: from epidural to delivery (expected average: 24 hours) ]
  11. Counts of normal vaginal delivery [ Time Frame: from epidural to delivery (expected average: 24 hours) ]
  12. Counts of assisted vaginal delivery [ Time Frame: from epidural to delivery (expected average: 24 hours) ]
  13. Counts of Cesarean delivery [ Time Frame: from epidural to delivery (expected average: 24 hours) ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975660


Contacts
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Contact: Brendan Carvalho, MBBCh, FRCA (650) 861-8607 brendan.carvalho@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Brendan Carvalho, MBBCh, FRCA Stanford University
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Responsible Party: Brendan Carvalho, Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03975660    
Other Study ID Numbers: 51101
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations