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Evaluation of Objective Pain Measurement Device

Primary Purpose

Pain, Analgesia, Labor Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Measurement Device
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1 Device Calibration

Part 2 Device Validation

Arm Description

50 patients requesting epidural labor analgesia will have pain levels monitored during labor.

60 patients requesting epidural labor analgesia will have pain levels monitored during labor.

Outcomes

Primary Outcome Measures

Average device pain score
Average pain score obtained by device validated measure (higher scores correspond to more pain)
Average self-report pain score
Average patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain)
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.
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.
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.
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.

Secondary Outcome Measures

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 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
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)
Device recorded pain scores for each contraction until 45 min after block
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
Count of participants with block failures
Count of participants with maternal side effects
Monitored maternal side effects will include nausea, pruritis, hypotension
Count of participants with fetal side effects
Monitored fetal side effects include fetal decelerations early/variable/late
Count of participants need Physician intervention
Time from epidural to delivery
Counts of normal vaginal delivery
Counts of assisted vaginal delivery
Counts of Cesarean delivery

Full Information

First Posted
June 1, 2019
Last Updated
April 14, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03975660
Brief Title
Evaluation of Objective Pain Measurement Device
Official Title
Evaluation of Objective Pain Measurement Device
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Analgesia, Labor Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Device Calibration
Arm Type
Experimental
Arm Description
50 patients requesting epidural labor analgesia will have pain levels monitored during labor.
Arm Title
Part 2 Device Validation
Arm Type
Experimental
Arm Description
60 patients requesting epidural labor analgesia will have pain levels monitored during labor.
Intervention Type
Device
Intervention Name(s)
Pain Measurement Device
Intervention Description
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 Measure Information:
Title
Average device pain score
Description
Average pain score obtained by device validated measure (higher scores correspond to more pain)
Time Frame
During labor up to 2 hours after epidural
Title
Average self-report pain score
Description
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
Title
Correlation between pain score and brain oxygenation
Description
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
Title
Correlation between pain score and noninvasive blood pressure
Description
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
Title
Correlation between pain score and heart rate
Description
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
Title
Correlation between pain score and pulse oximetry
Description
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.
Time Frame
During labor up to 2 hours after epidural
Secondary Outcome Measure Information:
Title
Time to reach pain score 2 or less out of 10
Description
Pain score on 0 to 10 scale (higher scores correspond to more pain)
Time Frame
within 45 minutes after the block placement
Title
Time taken for pain device score to be below validated value
Description
Validated value is from the validated reading recorded by the sensor in the pilot study
Time Frame
within 45 minutes after the block placement
Title
Patient reported pain scores after each contraction until 45 min after block
Description
Pain score on 0 to 10 scale (higher scores correspond to more pain)
Time Frame
within 45 minutes after the block placement
Title
Device recorded pain scores for each contraction until 45 min after block
Description
Device pain score validated measure (higher scores correspond to more pain)
Time Frame
within 45 minutes after the block placement
Title
Dermatomal level at 45 minutes after block placement as a measure of sensory blockade level
Time Frame
45 minutes
Title
Count of participants with block failures
Time Frame
within 45 minutes after the block placement
Title
Count of participants with maternal side effects
Description
Monitored maternal side effects will include nausea, pruritis, hypotension
Time Frame
within 45 minutes after the block placement
Title
Count of participants with fetal side effects
Description
Monitored fetal side effects include fetal decelerations early/variable/late
Time Frame
within 45 minutes after the block placement
Title
Count of participants need Physician intervention
Time Frame
within 45 minutes after the block placement
Title
Time from epidural to delivery
Time Frame
from epidural to delivery (expected average: 24 hours)
Title
Counts of normal vaginal delivery
Time Frame
from epidural to delivery (expected average: 24 hours)
Title
Counts of assisted vaginal delivery
Time Frame
from epidural to delivery (expected average: 24 hours)
Title
Counts of Cesarean delivery
Time Frame
from epidural to delivery (expected average: 24 hours)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brendan Carvalho, MBBCh, FRCA
Phone
(650) 861-8607
Email
brendan.carvalho@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Carvalho, MBBCh, FRCA
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Objective Pain Measurement Device

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