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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Electrical Epidural Stimulation Test for labor pain?

Research on a similar treatment, Transcutaneous Electrical Nerve Stimulation (TENS), suggests it can help manage labor pain and improve patient satisfaction, indicating that electrical stimulation methods may be effective for labor pain relief. ^{1 2 3 4 5}

Is electrical stimulation safe for managing labor pain?

Research on electrical stimulation for labor pain, such as Transcutaneous Electrical Nerve Stimulation (TENS), suggests it is generally safe for use in humans. Studies have focused on its effectiveness and patient satisfaction, with no significant safety concerns reported. ^{2 5 6 7 8}

How does electrical stimulation differ from other treatments for labor pain?

Electrical stimulation, specifically transcutaneous electrical nerve stimulation (TENS), is unique because it uses electrical currents applied through the skin to relieve labor pain, unlike traditional methods that often involve medications or injections. This non-invasive approach can be an alternative for those seeking pain relief without drugs. ^{1 2 3 5 7}

What is the purpose of this trial?

The aim of this study is to address the problem of epidural failure. The investigators theorize epidural failure can be due to inappropriate catheter movement and this may be related to the length of which the epidural catheter is inserted. The investigators will use electrical stimulation to determine if the catheter moved in the sacral direction with insertion.

Research Team

Steven Abboud, MD

Principal Investigator

Clinical Instructor, Anesthesiology, Perioperative and Pain Medicine

Eligibility Criteria

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

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

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

I am eligible for safe epidural placement.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-dose intrathecal local anesthetic does not increase the threshold current for the epidural stimulation test: a prospective observational trial of neuraxial analgesia in labouring women. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in labour pain: a systematic review. [2019]

3. Scotland pubmed.ncbi.nlm.nih.gov

The use of transcutaneous electrical nerve stimulation (TENS) for pain relief in labour: a review of the evidence. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation does not augment combined spinal epidural labour analgesia. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation for Pain Management for Women in Labor. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The epidural electric stimulation test does not predict local anesthetic spread or consumption in labour epidural analgesia. [2014]

7. France pubmed.ncbi.nlm.nih.gov

[Transcutaneous electric stimulation of the brain: a comparative study of the effects of its combination with peridural anesthesia using bupivacaine-fentanyl during obstetrical analgesia]. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

Pain relief in labour by transcutaneous electrical nerve stimulation (TENS). [2019]