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The Use of Electrical Stimulation for Determination of Epidural Catheter Placement

Primary Purpose

Obstetric Pain, Anesthesia, Local

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical Epidural Stimulation Test
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, Epidural Failure

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Pregnant female requesting epidural for labor analgesia. Must meet standard inclusion criteria for safe epidural placement. Platelet count over 70,000, INR under 1.3. Exclusion Criteria: Unable to safely place epidural catheter due to commonly accepted patient factors.

Sites / Locations

  • Lucile Packard Childrens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical Epidural Stimulation Test

Arm Description

Laboring women who request epidural analgesia will be given an electric stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.

Outcomes

Primary Outcome Measures

Incidence rate of sacral stimulation
Electrical stimulation will be performed at incremental points during catheter pull back with documentation of where stimulation was seen.

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT06055686
Brief Title
The Use of Electrical Stimulation for Determination of Epidural Catheter Placement
Official Title
The Use of Electrical Stimulation for Determination of Epidural Catheter Placement
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
We aim to address the problem of epidural failure. We theorize epidural failure can be due to inappropriate catheter movement and this may be related to the length of which the epidural catheter is inserted. We will use electrical stimulation to determine if the catheter moved in the sacral direction with insertion.
Detailed Description
The research participants will be pregnant women in Labor and Delivery ward of Stanford University hospital who request an epidural for labor analgesia. In our study the patients will receive an epidural catheter in the same way as standard of care. The catheter will be inserted to 20cm and then electrically stimulated to document where it is placed by looking at the muscles effected. The catheter is then pulled back in 5cm increments and stimulated until the standard distance is achieved. For example, if loss of resistance happened at 5cm, the catheter would be inserted to 20cm, stimulated, pulled back to 15cm and stimulated, and finally to 10cm and stimulated. Electrical stimulation of epidural catheters for confirmation of placement is a published and accepted technique. In this study, we will perform electrical stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.

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, Epidural Failure

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Electrical Epidural Stimulation Test
Arm Type
Experimental
Arm Description
Laboring women who request epidural analgesia will be given an electric stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electrical Epidural Stimulation Test
Intervention Description
Electrical stimulation test measures sensory/motor responses
Primary Outcome Measure Information:
Title
Incidence rate of sacral stimulation
Description
Electrical stimulation will be performed at incremental points during catheter pull back with documentation of where stimulation was seen.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant female requesting epidural for labor analgesia. Must meet standard inclusion criteria for safe epidural placement. Platelet count over 70,000, INR under 1.3. Exclusion Criteria: Unable to safely place epidural catheter due to commonly accepted patient factors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ksenia Kasimova, MD
Phone
6507889458
Email
kasimova@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Abboud, MD
Organizational Affiliation
Clinical Instructor, Anesthesiology, Perioperative and Pain Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Lucile Packard Childrens Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32522156
Citation
Kim YS, Kim HS, Jeong H, Lee CH, Lee MK, Choi SS. Efficacy of electrical stimulation on epidural anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2020 Jun 10;20(1):146. doi: 10.1186/s12871-020-01063-1.
Results Reference
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PubMed Identifier
17350527
Citation
Charghi R, Chan SY, Kardash KJ, Finlayson RJ, Tran DQ. Electrical stimulation of the epidural space using a catheter with a removable stylet. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):152-6. doi: 10.1016/j.rapm.2006.10.006.
Results Reference
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PubMed Identifier
30675686
Citation
Kwofie MK, Launcelott G, Tsui BCH. Determination of thoracic epidural catheter placement: electrical epidural stimulation (Tsui test) is simple, effective, and under-utilized. Can J Anaesth. 2019 Apr;66(4):360-364. doi: 10.1007/s12630-019-01302-1. Epub 2019 Jan 23. No abstract available.
Results Reference
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Learn more about this trial

The Use of Electrical Stimulation for Determination of Epidural Catheter Placement

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