Electrical Stimulation Test for Labor Pain

Overseen By Ksenia Kasimova, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Unsafe epidural placement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to verify the correct movement of an epidural catheter, a small tube used for pain relief during childbirth. The study employs electrical epidural stimulation to determine if the catheter moves properly, potentially addressing issues when epidurals fail to work as expected. It targets pregnant women who desire an epidural during labor and have no contraindications, such as an unhealthy blood count. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance epidural effectiveness for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this electrical epidural stimulation test is safe for laboring women?

Research has shown that using electrical epidural stimulation to locate the correct spot for epidurals is safe. Studies on its use for managing labor pain have not identified any major safety issues. Past research indicates that patients generally tolerate it well, and it works effectively, with many patients expressing satisfaction. These findings are promising for those considering this treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Electrical Epidural Stimulation Test for labor pain because it offers a novel approach to managing discomfort during childbirth. Unlike traditional epidural analgesia, which relies on continuous medication to block pain, this method uses incremental electrical stimulation to potentially pinpoint and control pain more precisely. By refining how pain signals are managed, this technique could enhance pain relief while minimizing medication use, offering a more targeted and potentially safer option for laboring women.

What evidence suggests that the Electrical Epidural Stimulation Test is effective for labor pain?

This trial will evaluate the use of electrical stimulation during labor to relieve pain and increase maternal satisfaction. Research has shown that using electrical stimulation to confirm the correct spot for an epidural can improve the procedure's success. One study found that this method provided excellent pain relief, with a significant drop in pain levels after starting the epidural. Although transcutaneous electrical nerve stimulation (TENS) has shown some benefits for labor pain, the evidence is not as strong. Overall, electrical stimulation, especially when combined with epidurals, appears promising for effectively managing labor pain. ^{2 3 4 5 6}

Who Is on the Research Team?

Steven Abboud, MD

Principal Investigator

Clinical Instructor, Anesthesiology, Perioperative and Pain Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant women seeking epidural pain relief during labor who meet the standard safety criteria for epidural placement, have a platelet count over 70,000, and an INR under 1.3. Women who cannot safely receive an epidural due to common health factors are not eligible.

Inclusion Criteria

Your platelet count should be over 70,000, and your INR should be under 1.3.

I am eligible for safe epidural placement.

Pregnant women who want to use epidural for pain relief during labor.

Exclusion Criteria

You are not able to safely have a catheter placed in your spine for pain relief.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an epidural catheter with electrical stimulation to determine placement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrical Epidural Stimulation Test

Trial Overview The study is testing whether electrical stimulation can help determine if an epidural catheter has moved in the wrong direction during insertion, which could lead to failure of the anesthesia.

How Is the Trial Designed?

Group I: Electrical Epidural Stimulation Test Experimental Treatment 1 Intervention

Laboring women who request epidural analgesia will be given an electric stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Transcutaneous electrical nerve stimulation (TENS) showed weak evidence for reducing pain during labor based on a systematic review of eight trials involving 712 women.

While TENS may reduce the likelihood of needing additional pain relief during labor, the overall analgesic effect is not compelling, suggesting that any observed benefits could be due to biases in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in labour pain: a systematic review. Carroll, D., Tramèr, M., McQuay, H., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8022049/

Evaluating the effectiveness of TENS for maternal ... In the epidural group, all patients had excellent pain relief with significant VAS score reductions after 30 min of initiation of technique. ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03161717

Study Details | NCT03161717 | Efficacy and Safety of ... Pain relief in labor is assessed by a change in the visual analogue scale (VAS) score. A 10 point VAS, where 0 is no pain and 10 is unbearable ...

3. withpower.com withpower.com/trial/phase-labor-pain-9-2023-27f82

Electrical Stimulation Test for Labor Pain · Info for Participants Transcutaneous electrical nerve stimulation (TENS) showed weak evidence for reducing pain during labor based on a systematic review of eight trials involving ...

4. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-020-01063-1

Efficacy of electrical stimulation on epidural anesthesia for ... Confirmation of the epidural space using electrical stimulation improved success rate as well as maternal satisfaction without wasting time, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7905652/

The effects of transcutaneous electrical nerve stimulation ... This study indicates that TENS can be used as a non-pharmacological therapy to reduce pain and shorten the active labor phase.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7285553/

Efficacy of electrical stimulation on epidural anesthesia for ... The purpose of this study was to assess the efficacy and safety of electrical stimulation to identify epidural spaces in cesarean section.