Evaluation of Objective Pain Measurement Device

Not Applicable

Completed

Conditions: Analgesia
Pain
Labor Pain

Registration Number: NCT03975660

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 110

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation Between Pain Score and Noninvasive Blood Pressure	During labor up to 2 hours after epidural	Pearson 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.
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 of Average Device Pain Score to Average Self-report Pain Score	During labor up to 2 hours after epidural	Pearson correlation
Correlation Between Pain Score and Brain Oxygenation	During labor up to 2 hours after epidural	Pearson 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 Heart Rate	During labor up to 2 hours after epidural	Pearson 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 (Sp02). This outcome will be assessed in part 2 only.

Secondary Outcome Measures

Name	Time	Method
Count of Participants With Cesarean Delivery	from epidural to delivery (expected average: 24 hours)
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 Block	Up to approximately 45 minutes after the block placement	Pain score on 0 to 10 scale (higher scores correspond to more pain). Pain scores were obtained at random intervals and the scores were summed and averaged to create the reported score. Patients stopped rating pain once the level dropped to zero.
Device Recorded Pain Scores After Block	Up to approximately 45 minutes after the block placement	Device pain score validated measure (range: 0 to 10, higher scores correspond to more pain). Pain scores were obtained at random intervals and the scores were summed and averaged to create the reported score. Device recording was discontinued when pain level dropped to zero.
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 Needing Physician Intervention	within 45 minutes after the block placement
Time From Epidural to Delivery	from epidural to delivery (average approximately 9 hours)
Count of Participants With Normal Vaginal Delivery	from epidural to delivery (expected average: 24 hours)
Count of Participants With Assisted Vaginal Delivery	from epidural to delivery (expected average: 24 hours)