NCT04983511

Brief Summary

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.

Trial Health

65
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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Nov 2025

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 Progress48%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

July 20, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
4.3 years until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

July 20, 2021

Last Update Submit

April 30, 2025

Conditions

Keywords

Electrical Epidural Stimulation Test

Outcome Measures

Primary Outcomes (1)

  • Electrical Epidural Stimulation Test

    Investigate the ability of the electrical epidural stimulation test (EST) to predict epidural catheter reactivation.

    Duration of EST test (approximately 1-2 hours)

Study Arms (1)

Electrical Epidural Stimulation Test (EST)

EXPERIMENTAL

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)

Interventions

EST measures sensory/motor responses

Electrical Epidural Stimulation Test (EST)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Carvalho JC, Khemka R, Loke J, Tsui BC. 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. Can J Anaesth. 2015 Mar;62(3):265-70. doi: 10.1007/s12630-014-0291-x. Epub 2014 Dec 11.

  • Delgado C, Van Cleve W, Kent C, Dinges E, Bollag LA. Neuraxial anesthesia for postpartum tubal ligation at an academic medical center. F1000Res. 2018 Sep 26;7:1557. doi: 10.12688/f1000research.16025.1. eCollection 2018.

  • Tsui BC, Gupta S, Finucane B. Confirmation of epidural catheter placement using nerve stimulation. Can J Anaesth. 1998 Jul;45(7):640-4. doi: 10.1007/BF03012093.

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ban C.H. Tsui, MD

CONTACT

Ksenia Kasimova, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients with deactivated epidural/CSE catheters will be given electrical epidural stimulation test to detect its ability to be reactivated.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-Med Ctr Line

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 30, 2021

Study Start

November 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share