N/A
Completed N=130
Evaluation of Objective Pain Measurement Device
Postoperative Pain · Analgesia
Source: ClinicalTrials.gov NCT03975660 ↗
Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Average Self-report Pain Score — 4.08 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Self-report Pain Score |
4.08 | — |
| PRIMARY Correlation of Average Device Pain Score to Average Self-report Pain Score |
0.79 | — |
| PRIMARY Correlation Between Pain Score and Brain Oxygenation |
0.05 | — |
| PRIMARY Correlation Between Pain Score and Noninvasive Blood Pressure |
0.20; 0.22 | — |
| PRIMARY Correlation Between Pain Score and Heart Rate |
0.20 | — |
| PRIMARY Correlation Between Pain Score and Pulse Oximetry |
0.05 | — |
| SECONDARY Time to Reach Pain Score 2 or Less Out of 10 |
17.2 | — |
| SECONDARY Time Taken for Pain Device Score to be Below Validated Value |
16.6 | — |
| SECONDARY Patient Reported Pain Scores After Block |
2.0; 2.0; 1.0 | — |
| SECONDARY Device Recorded Pain Scores After Block |
2.9; 2.7; 1.5 | — |
| SECONDARY Dermatomal Level at 45 Minutes After Block Placement as a Measure of Sensory Blockade Level |
— | — |
| SECONDARY Count of Participants With Block Failures |
18 | — |
| SECONDARY Count of Participants With Maternal Side Effects |
— | — |
| SECONDARY Count of Participants With Fetal Side Effects |
— | — |
| SECONDARY Count of Participants Needing Physician Intervention |
— | — |
| SECONDARY Time From Epidural to Delivery |
560 | — |
| SECONDARY Count of Participants With Normal Vaginal Delivery |
109 | — |
| SECONDARY Count of Participants With Assisted Vaginal Delivery |
2 | — |
| SECONDARY Count of Participants With Cesarean Delivery |
19 | — |
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
Data sourced from ClinicalTrials.gov (NCT03975660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.