Evaluation of Objective Pain Measurement Device

Pain Clinical Trial

Official title:

Evaluation of Objective Pain Measurement Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03975660
• Other study ID #: 51101
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Brendan Carvalho, MBBCh, FRCA
• Phone: (650) 861-8607
• Email: brendan.carvalho[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Labor Pain
• Pain

Intervention

Device:
• Pain Measurement Device
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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average device pain score	Average pain score obtained by device validated measure (higher scores correspond to more pain)	During labor up to 2 hours after epidural
Primary	Average self-report pain score	Average patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain)	During labor up to 2 hours after epidural
Primary	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.	During labor up to 2 hours after epidural
Primary	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.	During labor up to 2 hours after epidural
Primary	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.	During labor up to 2 hours after epidural
Primary	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.	During labor up to 2 hours after epidural
Secondary	Time to reach pain score 2 or less out of 10	Pain score on 0 to 10 scale (higher scores correspond to more pain)	within 45 minutes after the block placement
Secondary	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	within 45 minutes after the block placement
Secondary	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)	within 45 minutes after the block placement
Secondary	Device recorded pain scores for each contraction until 45 min after block	Device pain score validated measure (higher scores correspond to more pain)	within 45 minutes after the block placement
Secondary	Dermatomal level at 45 minutes after block placement as a measure of sensory blockade level		45 minutes
Secondary	Count of participants with block failures		within 45 minutes after the block placement
Secondary	Count of participants with maternal side effects	Monitored maternal side effects will include nausea, pruritis, hypotension	within 45 minutes after the block placement
Secondary	Count of participants with fetal side effects	Monitored fetal side effects include fetal decelerations early/variable/late	within 45 minutes after the block placement
Secondary	Count of participants need Physician intervention		within 45 minutes after the block placement
Secondary	Time from epidural to delivery		from epidural to delivery (expected average: 24 hours)
Secondary	Counts of normal vaginal delivery		from epidural to delivery (expected average: 24 hours)
Secondary	Counts of assisted vaginal delivery		from epidural to delivery (expected average: 24 hours)
Secondary	Counts of Cesarean delivery		from epidural to delivery (expected average: 24 hours)