NCT06055686

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Nov 2025Nov 2026

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2.1 years until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

September 20, 2023

Last Update Submit

April 30, 2025

Conditions

Keywords

Electrical Epidural Stimulation TestEpidural Failure

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of sacral stimulation

    Electrical stimulation will be performed at incremental points during catheter pull back with documentation of where stimulation was seen.

    1 year

Study Arms (1)

Electrical Epidural Stimulation Test

EXPERIMENTAL

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

Interventions

Electrical stimulation test measures sensory/motor responses

Electrical Epidural Stimulation Test

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant female requesting epidural for labor analgesia.
  • Platelet count over 70,000, INR under 1.3.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Childrens Hospital

Stanford, California, 94305, United States

Location

Related Publications (3)

  • Kim YS, Kim HS, Jeong H, Lee CH, Lee MK, Choi SS. Efficacy of electrical stimulation on epidural anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2020 Jun 10;20(1):146. doi: 10.1186/s12871-020-01063-1.

    PMID: 32522156BACKGROUND
  • Charghi R, Chan SY, Kardash KJ, Finlayson RJ, Tran DQ. Electrical stimulation of the epidural space using a catheter with a removable stylet. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):152-6. doi: 10.1016/j.rapm.2006.10.006.

    PMID: 17350527BACKGROUND
  • Kwofie MK, Launcelott G, Tsui BCH. Determination of thoracic epidural catheter placement: electrical epidural stimulation (Tsui test) is simple, effective, and under-utilized. Can J Anaesth. 2019 Apr;66(4):360-364. doi: 10.1007/s12630-019-01302-1. Epub 2019 Jan 23. No abstract available.

    PMID: 30675686BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Abboud, MD

    Clinical Instructor, Anesthesiology, Perioperative and Pain Medicine

    STUDY DIRECTOR

Central Study Contacts

Ksenia Kasimova, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-Med Ctr Line

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations