NCT04109365

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

September 11, 2019

Last Update Submit

April 30, 2025

Conditions

Obstetric PainAnesthesia, Local

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 determine the position of the epidural catheter anesthesia for labour analgesia after low-dose anesthetic as compared to the gold standard of clinical assessment.

    Duration of EST test (approximately 1-2 hours)

Secondary Outcomes (1)

  • Pain Scores

    Approximately 3 hours following introduction of anesthetics through the catheter.

Study Arms (1)

Electrical Epidural Stimulation Test (EST)

EXPERIMENTAL

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.

Diagnostic Test: Electrical Epidural Stimulation Test (EST)

Interventions

Electrical Epidural Stimulation Test (EST)DIAGNOSTIC_TEST

EST measures sensory/motor responses

Electrical Epidural Stimulation Test (EST)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsObstetric related study
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
  • Full-term pregnancy with request for epidural early in labour (i.e. Regular labor or C-Section)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25501494RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Chynna Villanueva, BS, RN

CONTACT

6504986346chynnav@stanford.edu

Study Design

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

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 30, 2019

Study Start

December 15, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)