Obstetric Placement Study Using EST

NCT ID: NCT04109365

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obstetric Pain Anesthesia, Local

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Electrical Epidural Stimulation Test (EST)

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.

Group Type EXPERIMENTAL

Electrical Epidural Stimulation Test (EST)

Intervention Type DIAGNOSTIC_TEST

EST measures sensory/motor responses

Interventions

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Electrical Epidural Stimulation Test (EST)

EST measures sensory/motor responses

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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)

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Chi-Ho Ban Tsui

Professor-Med Ctr Line

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lucille Packard Children's Hospital

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chynna Villanueva, BS, RN

Role: CONTACT

6504986346

Facility Contacts

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Ban Tsui, MD

Role: primary

650-200-9107

References

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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.

Reference Type RESULT
PMID: 25501494 (View on PubMed)

Other Identifiers

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52856

Identifier Type: -

Identifier Source: org_study_id

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