Pain Measurement Device for Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pain+2 MorePain Measurement Device - Device
Eligibility
18 - 45
Female
What conditions do you have?
Select

Study Summary

This trial will test a new device that attempts to measure pain objectively. The device will be applied to patients during routine clinical care to see if it correlates with the patients' verbal pain ratings and analgesia requirements. A brain oxygenation device will be used to monitor brain oxygenation and hemodynamics to see if there is a relationship between the new device's objective measure of pain and brain oxygenation/hemodynamic changes and patient-reported pain.

Eligible Conditions
  • Pain
  • Labor Pain
  • Pain relief

Treatment Effectiveness

Study Objectives

6 Primary · 13 Secondary · Reporting Duration: 45 minutes

45 minutes
Dermatomal level at 45 minutes after block placement as a measure of sensory blockade level
Hour 2
Average device pain score
Average self-report pain score
Correlation between pain score and brain oxygenation
Correlation between pain score and heart rate
Correlation between pain score and noninvasive blood pressure
Correlation between pain score and pulse oximetry
Hour 24
Counts of Cesarean delivery
Counts of assisted vaginal delivery
Counts of normal vaginal delivery
Time from epidural to delivery
within 45 minutes after the block placement
Count of participants need Physician intervention
Count of participants with block failures
Count of participants with fetal side effects
Count of participants with maternal side effects
Device recorded pain scores for each contraction until 45 min after block
Patient reported pain scores after each contraction until 45 min after block
Time taken for pain device score to be below validated value
Time to reach pain score 2 or less out of 10

Trial Safety

Trial Design

4 Treatment Groups

Dural puncture epidural (DPE)
1 of 4
Combined spinal-epidural (CSE)
1 of 4
Part 1 Device Calibration
1 of 4
Part 2 Device Validation
1 of 4

Experimental Treatment

110 Total Participants · 4 Treatment Groups

Primary Treatment: Pain Measurement Device · No Placebo Group · N/A

Dural puncture epidural (DPE)
Device
Experimental Group · 1 Intervention: Pain Measurement Device · Intervention Types: Device
Combined spinal-epidural (CSE)
Device
Experimental Group · 1 Intervention: Pain Measurement Device · Intervention Types: Device
Part 1 Device Calibration
Device
Experimental Group · 1 Intervention: Pain Measurement Device · Intervention Types: Device
Part 2 Device Validation
Device
Experimental Group · 1 Intervention: Pain Measurement Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 45 minutes

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,161 Previous Clinical Trials
35,686,932 Total Patients Enrolled
38 Trials studying Pain
4,910 Patients Enrolled for Pain
Brendan Carvalho, MBBCh, FRCAPrincipal InvestigatorStanford University
2 Previous Clinical Trials
111 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a clear toco tracing (clearly showing contractions at least every 5 minutes).
You have pain score greater than or equal to 3 out of 10 with contractions.
You have an ASA class 1 or 3 +/-E.