Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population

April 30, 2025 updated by: Chi-Ho Ban Tsui, Stanford University
Following labor, epidural or combined spinal-epidural (CSE) catheters are kept in place and deactivated. However, many women opt for procedures such as tubal ligation, which may require epidural anesthesia as a method of pain relief. Our study aims to confirm the ability to predict reactivation of epidural catheter in postpartum females through the electrical epidural stimulation test (EST) which was first described by the PI of this study approximately 20 years ago.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, investigators hope to investigate the ability of the electrical epidural stimulation test (EST) to predict reactivation of epidural catheter in postpartum females. The standard practice for confirming the reactivation of epidural or CSE catheters requires methods such as dosing the local anesthetic. With the EST test this will allow for the anesthesiologist to determine whether or not the epidural can be activated immediately.

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact Backup

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females, 18 years and older
  • American Society of Anesthesiologists physical status I or II
  • Status post natural labor/birth process or C-section
  • Has epidural or CSE catheter
  • Upcoming procedure requiring epidural/CSE anesthesia for pain management

Exclusion Criteria:

  • Contraindication to regional anesthesia
  • Allergy or hypersensitivity to lidocaine, bupivacaine, or fentanyl
  • Use of sedatives or opioids
  • Abnormal vertebrae anatomy
  • Neurological disorder with lumbar involvement
  • Implanted electronic devices
  • Did not receive epidural or CSE anesthesia

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 (EST)
Postpartum women are given EST to predict epidural catheter reactivation for their subsequent procedures (i.e. tubal ligation).
Diagnostic test: Electrical Epidural Stimulation Test (EST)
EST measures sensory/motor responses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrical Epidural Stimulation Test
Time Frame: Duration of EST test (approximately 1-2 hours)
Investigate the ability of the electrical epidural stimulation test (EST) to predict epidural catheter reactivation.
Duration of EST test (approximately 1-2 hours)

Collaborators and Investigators

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

Sponsor

Stanford University

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)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 30, 2021

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

  • 61999

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

No

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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