The Use of Electrical Stimulation for Determination of Epidural Catheter Placement

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06055686
Collaborator
(none)
50
1
1
12
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Electrical Epidural Stimulation Test
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Use of Electrical Stimulation for Determination of Epidural Catheter Placement
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Electrical Epidural Stimulation Test

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.

Diagnostic Test: Electrical Epidural Stimulation Test
Electrical stimulation test measures sensory/motor responses

Outcome Measures

Primary Outcome Measures

  1. Incidence rate of sacral stimulation [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lucile Packard Childrens Hospital Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Study Director: Steven Abboud, MD, Clinical Instructor, Anesthesiology, Perioperative and Pain Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University
ClinicalTrials.gov Identifier:
NCT06055686
Other Study ID Numbers:
  • 71662
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023