EST for Labor Pain

Overseen By Chynna Villanueva, BS, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

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

Compensation: Varies

Number of Visits: 1

Duration: 1-2 hours

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Combined spinal-epidural (CSE) is an established technique for providing labour analgesia to obstetric patients which provides rapid onset but unsustained analgesia. The epidural catheter can be used to extend and provide continuous pain relief, however during single-segment needle-through-needle CSE, the catheter is untested. This study aims to confirm placement of epidural catheters of anesthesia through the epidural stimulation test (EST) which was first described by the PI of the study for confirming placement of epidural catheters approximately 20 years ago.

Will I have to stop taking my current medications?

The trial requires that you do not use sedatives or opioids, so you would need to stop taking those medications if you are currently using them.

What data supports the effectiveness of the treatment Electrical Epidural Stimulation Test (EST) for labor pain?

While there is no direct evidence for Electrical Epidural Stimulation Test (EST) in labor pain, studies on a similar treatment, Transcutaneous Electrical Nerve Stimulation (TENS), show that it can provide pain relief during labor, with 87% of participants experiencing some relief and 20% reporting excellent relief. ^{1 2 3 4 5}

Is electrical stimulation safe for managing labor pain?

Transcutaneous electrical nerve stimulation (TENS), a type of electrical stimulation, has been used for managing labor pain and is generally considered safe. Studies have shown that TENS can provide pain relief during labor without significant safety concerns. ^{1 3 4 6 7}

How is the Electrical Epidural Stimulation Test (EST) treatment different from other treatments for labor pain?

The Electrical Epidural Stimulation Test (EST) is unique because it is used to confirm the correct placement of the epidural catheter during labor, ensuring effective pain relief. Unlike other treatments like Transcutaneous Electrical Nerve Stimulation (TENS), which is applied externally to modulate pain, EST is specifically used in conjunction with epidural analgesia to enhance its accuracy and effectiveness. ^{1 3 6 7 8}

Eligibility Criteria

This trial is for women over 18 who are in full-term pregnancy and want epidural pain relief during labor or C-section. They should be generally healthy (ASA I or II). It's not for those with allergies to certain anesthetics, sedative/opioid use, abnormal spine anatomy, neurological issues affecting the lower back, or implanted electronic devices.

Inclusion Criteria

I am in good or mild systemic disease state according to anesthesia standards.

I am a woman aged 18 or older.

You are in the late stages of pregnancy and have asked for an epidural at the start of labor.

Exclusion Criteria

I am currently using sedatives or opioids.

My spine's structure is not normal.

I have a nerve condition affecting my lower back.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo the Electrical Epidural Stimulation Test (EST) to confirm epidural catheter placement before and after anesthetic administration

1-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for pain scores approximately 3 hours after anesthetic introduction

3 hours

Treatment Details

Interventions

• Electrical Epidural Stimulation Test (EST)

Trial Overview The study tests a method called Electrical Epidural Stimulation Test (EST) to confirm correct placement of epidural catheters used for continuous pain relief during childbirth. This technique was developed by the principal investigator about two decades ago.

Participant Groups

Group I: Electrical Epidural Stimulation Test (EST) Experimental Treatment 1 Intervention

Laboring women are given EST test initially before local anesthetic is administered and 1 hour post-anesthetic in order to measure sensory and motor responses.

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

Transcutaneous electrical nerve stimulation for relief of parturition pain. A clinical report. [2019]

5. 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]

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. Germany pubmed.ncbi.nlm.nih.gov

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

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

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