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Pain Measurement Device for Pain Management

N/A

Recruiting

Led By Brendan Carvalho, MBBCh, FRCA

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient requesting epidural labor analgesia

Age 18-50

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 45 minutes

Awards & highlights

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.

Who is the study for?

This trial is for pregnant individuals aged 18-50 seeking epidural labor analgesia, with a pain score of at least 3 out of 10 due to contractions. They must be able to give informed consent in English and have no history of chronic pain or opioid use, BMI over 45, allergies to sensor adhesive material or local anesthetics/opioids.Check my eligibility

What is being tested?

The study tests an experimental device designed to measure pain objectively during labor. It will compare verbal pain ratings and the need for analgesics with readings from the device. Brain oxygenation and hemodynamics are also monitored to see how they relate to measured and reported pain levels.See study design

What are the potential side effects?

Since this trial involves a non-invasive measurement device, side effects may include discomfort or skin irritation from the sensor adhesive material used by the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I want an epidural for pain relief during labor.

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I am between 18 and 50 years old.

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My pain level is 3 or more on a scale of 10 during contractions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 45 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~45 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average device pain score

Average self-report pain score

Correlation between pain score and brain oxygenation

+3 more

Secondary outcome measures

Count of participants need Physician intervention

Count of participants with block failures

Count of participants with fetal side effects

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 Device ValidationExperimental Treatment1 Intervention

60 patients requesting epidural labor analgesia will have pain levels monitored during labor.

Group II: Part 1 Device CalibrationExperimental Treatment1 Intervention

50 patients requesting epidural labor analgesia will have pain levels monitored during labor.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,240 Total Patients Enrolled

42 Trials studying Pain

5,266 Patients Enrolled for Pain

Brendan Carvalho, MBBCh, FRCAPrincipal InvestigatorStanford University

2 Previous Clinical Trials

111 Total Patients Enrolled

Media Library

Pain Measurement Device Clinical Trial Eligibility Overview. Trial Name: NCT03975660 — N/A

Pain Research Study Groups: Part 1 Device Calibration, Part 2 Device Validation

Pain Clinical Trial 2023: Pain Measurement Device Highlights & Side Effects. Trial Name: NCT03975660 — N/A

Pain Measurement Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT03975660 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the prerequisites to join this investigation?

"For this clinical trial, 110 individuals aged 18-45 experiencing labour pain must be recruited. The prospective patients must also satisfy the following criteria: Age between 18 and 50, Requests epidural analgesia for childbirth relief, Contractions detected at least every 5 minutes on a toco tracing monitor; Pain score of 3 or higher concurrent with contractions; ASA 1 or 3 +/-E (American Society of Anesthesiologists Physical Status Classification)."

Answered by AI

Are there any remaining opportunities to enroll in this clinical investigation?

"The details listed on clinicialtrials.gov indicate that the project is actively soliciting recruits, with the initial posting occurring on November 1st 2019 and a subsequent amendment taking place April 14th 2022."

Answered by AI

How many individuals are currently undergoing the experiment?

"Indeed, clinicaltrials.gov's data confirms that this medical trial began enrolling patients on November 1st 2019 and is still recruiting as of April 14th 2022. Currently, the team behind it are looking to find 110 participants at one site."

Answered by AI