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Evaluation of Objective Pain Measurement Device

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ClinicalTrials.gov Identifier: NCT03975660
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
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.

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 correlation between pain scores from the device and actual pain scores reported by the patients and degree of nociceptive input (uterine contractions) and to 2) compare the device index score and pain scores (patient reported during uterine contractions) after two techniques different neuraxial blocks i.e. combined spinal epidural (CSE) and dural puncture epidural (DPE).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to either dural puncture epidural or combined spinal epidural in a 1:1 ratio.
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Objective Pain Measurement Device
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021

Arm Intervention/treatment
Experimental: Dural puncture epidural (DPE)
Patients will receive dural puncture epidural (DPE) and will have pain levels monitored by ROPA System (CereVu Medical, Inc. San Francisco, CA) during labor.
Device: Pain Measurement Device
When participants request labor analgesia, the sensor of the pain measurement device (ROPA System (CereVu Medical, Inc. San Francisco, CA) ) will be applied to the forehead and connected to the device. Data recording is then started.

Experimental: Combined spinal-epidural (CSE)
Patients will receive combined spinal-epidural (CSE) and will have pain levels monitored by ROPA System (CereVu Medical, Inc. San Francisco, CA) during labor.
Device: Pain Measurement Device
When participants request labor analgesia, the sensor of the pain measurement device (ROPA System (CereVu Medical, Inc. San Francisco, CA) ) 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)


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 18-45
  • ASA 1 or 2 +/-E
  • Patient requesting epidural labor analgesia
  • Patient in active labor (cervical change, greater than or equal to 3 cm)
  • 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
  • Severe co-morbidities

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 Not yet 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     History of Changes
Other Study ID Numbers: 51101
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms