Evaluation of Objective Pain Measurement Device

Stanford University

Status: Completed

Conditions: Labor Pain; Analgesia; Pain

Treatments: Device: Pain Measurement Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03975660

51101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Device Calibration and Validation

Experimental group

Description:

Patients requesting epidural labor analgesia will have pain levels monitored during labor.

Treatment:

Device: Pain Measurement Device