Recruiting

EST

Sponsor:

Stanford University

Code:

NCT04109365

Conditions

Obstetric Pain

Anesthesia, Local

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electrical Epidural Stimulation Test (EST)

Study Details

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.

Conditions

Obstetric Pain

Anesthesia, Local

Study ID

NCT04109365

Start date

Dec 15, 2020

Status verified date

Apr, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Electrical Epidural Stimulation Test (EST)

EST measures sensory/motor responses

Primary outcome measure

  • Electrical Epidural Stimulation Test [ Time Frame: Duration of EST test (approximately 1-2 hours) ]

Central Contacts and Locations

Central contacts

Chynna Villanueva, BS, RN

6504986346chynnav@stanford.edu

Locations

Lucille Packard Children's Hospital

Recruiting

Palo Alto, California, United States, 94304

Contacts

Ban Tsui, MD

650-200-9107bantsui@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

May 1, 2025

Last verified

Apr, 2025

Keywords

  • Electrical Epidural Stimulation Test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-05-01.