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NCT Number: NCT04109365

Obstetric Placement Study Using EST

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.

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Key information

Conditions

Obstetric Pain Anesthesia, Local Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Ban Tsui, MD

CONTACT

[email protected]

650-200-9107

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical Epidural Stimulation Test (EST)

Diagnostic Test

EST measures sensory/motor responses

Primary outcomes

  1. Electrical Epidural Stimulation Test

    Time frame: Duration 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 outcomes

  1. Pain Scores

    Time frame: Approximately 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chynna Villanueva, BS, RN

CONTACT

[email protected]

6504986346

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2019
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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