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Obstetric Placement Study Using EST

Electrical Epidural Stimulation Test for Confirmation of Epidural Catheter Placement in Labouring Women

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04109365
Enrollment
40
Registered
2019-09-30
Start date
2020-12-15
Completion date
2025-12-31
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Obstetric Pain

Keywords

Electrical Epidural Stimulation Test

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.

Interventions

EST measures sensory/motor responses

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Electrical Epidural Stimulation TestDuration of EST test (approximately 1-2 hours)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.

Secondary

MeasureTime frameDescription
Pain ScoresApproximately 3 hours following introduction of anesthetics through the catheter.Patients will be asked for a pain score by research staff approximately 3 hours following placement of the epidural catheter and low-dose anesthetics are introduced. The pain scores will be on a scale from 0-10 with 0 representing no pain and 10 representing maximum pain.

Countries

United States

Contacts

Primary ContactChynna Villanueva, BS, RN
chynnav@stanford.edu6504986346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026