Obstetric Placement Study Using EST

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local; Obstetric Pain
• Intervention / Treatment: Diagnostic test: Electrical Epidural Stimulation Test (EST)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chynna Villanueva, BS, RN; Phone Number: 6504986346; Email: chynnav@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Lucille Packard Children's Hospital
      • Contact: Ban Tsui, MD; Phone Number: 650-200-9107; Email: bantsui@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: Electrical Epidural Stimulation Test (EST); EST measures sensory/motor responses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	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.	Approximately 3 hours following introduction of anesthetics through the catheter.

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Electrical Epidural Stimulation Test
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 52856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No