Clinical trial NCT03975660: Evaluation of Objective Pain Measurement Device
Official title: Evaluation of Objective Pain Measurement Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Analgesia
Labor Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Average Self-report Pain Score
timeFrame: During labor up to 2 hours after epidural
measure: Correlation of Average Device Pain Score to Average Self-report Pain Score
timeFrame: During labor up to 2 hours after epidural
measure: Correlation Between Pain Score and Brain Oxygenation
timeFrame: During labor up to 2 hours after epidural
measure: Correlation Between Pain Score and Noninvasive Blood Pressure
timeFrame: During labor up to 2 hours after epidural
measure: Correlation Between Pain Score and Heart Rate
timeFrame: During labor up to 2 hours after epidural
measure: Correlation Between Pain Score and Pulse Oximetry
timeFrame: During labor up to 2 hours after epidural
Secondary outcomes:
measure: Time to Reach Pain Score 2 or Less Out of 10
timeFrame: within 45 minutes after the block placement
measure: Time Taken for Pain Device Score to be Below Validated Value
timeFrame: within 45 minutes after the block placement
measure: Patient Reported Pain Scores After Block
timeFrame: Up to approximately 45 minutes after the block placement
measure: Device Recorded Pain Scores After Block
timeFrame: Up to approximately 45 minutes after the block placement
measure: Dermatomal Level at 45 Minutes After Block Placement as a Measure of Sensory Blockade Level
timeFrame: 45 minutes
measure: Count of Participants With Block Failures
timeFrame: within 45 minutes after the block placement
measure: Count of Participants With Maternal Side Effects
timeFrame: within 45 minutes after the block placement
measure: Count of Participants With Fetal Side Effects
timeFrame: within 45 minutes after the block placement
measure: Count of Participants Needing Physician Intervention
timeFrame: within 45 minutes after the block placement
measure: Time From Epidural to Delivery
timeFrame: from epidural to delivery (average approximately 9 hours)
measure: Count of Participants With Normal Vaginal Delivery
timeFrame: from epidural to delivery (expected average: 24 hours)
measure: Count of Participants With Assisted Vaginal Delivery
timeFrame: from epidural to delivery (expected average: 24 hours)
measure: Count of Participants With Cesarean Delivery
timeFrame: from epidural to delivery (expected average: 24 hours)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Brendan Carvalho, MBBCh, FRCA
role: PRINCIPAL_INVESTIGATOR
References: