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Obstetric Placement Study Using EST

Primary Purpose

Obstetric Pain, Anesthesia, Local

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical Epidural Stimulation Test (EST)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstetric Pain focused on measuring Electrical Epidural Stimulation Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Lucille Packard Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical Epidural Stimulation Test (EST)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 11, 2019
Last Updated
September 20, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04109365
Brief Title
Obstetric Placement Study Using EST
Official Title
Electrical Epidural Stimulation Test for Confirmation of Epidural Catheter Placement in Labouring Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Pain, Anesthesia, Local
Keywords
Electrical Epidural Stimulation Test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrical Epidural Stimulation Test (EST)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electrical Epidural Stimulation Test (EST)
Intervention Description
EST measures sensory/motor responses
Primary Outcome Measure Information:
Title
Electrical Epidural Stimulation Test
Description
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.
Time Frame
Duration of EST test (approximately 1-2 hours)
Secondary Outcome Measure Information:
Title
Pain Scores
Description
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.
Time Frame
Approximately 3 hours following introduction of anesthetics through the catheter.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Obstetric related study
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chynna Villanueva, BS, RN
Phone
6504986346
Email
chynnav@stanford.edu
Facility Information:
Facility Name
Lucille Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ban Tsui, MD
Phone
650-200-9107
Email
bantsui@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25501494
Citation
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.
Results Reference
result

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Obstetric Placement Study Using EST

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