The Use of Electrical Stimulation for Determination of Epidural Catheter Placement

April 30, 2025 updated by: Chi-Ho Ban Tsui, Stanford University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The research participants will be pregnant women in Labor and Delivery ward of Stanford University hospital who request an epidural for labor analgesia.

In this study the patients will receive an epidural catheter in the same way as standard of care. The catheter will be inserted to 20cm and then electrically stimulated to document where it is placed by looking at the muscles effected. The catheter is then pulled back in 5cm increments and stimulated until the standard distance is achieved. For example, if loss of resistance happened at 5cm, the catheter would be inserted to 20cm, stimulated, pulled back to 15cm and stimulated, and finally to 10cm and stimulated.

Electrical stimulation of epidural catheters for confirmation of placement is a published and accepted technique. In this study, the investigators will perform electrical stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Lucile Packard Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant female requesting epidural for labor analgesia.
  • Must meet standard inclusion criteria for safe epidural placement.
  • Platelet count over 70,000, INR under 1.3.

Exclusion Criteria:

  • Unable to safely place epidural catheter due to commonly accepted patient factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical Epidural Stimulation Test
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.
Diagnostic test: Electrical Epidural Stimulation Test
Electrical stimulation test measures sensory/motor responses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of sacral stimulation
Time Frame: 1 year
Electrical stimulation will be performed at incremental points during catheter pull back with documentation of where stimulation was seen.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Study Director: Steven Abboud, MD, Clinical Instructor, Anesthesiology, Perioperative and Pain Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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