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NCT06055686 Clinical Trial

The Use of Electrical Stimulation for Determination of Epidural Catheter Placement

Anesthesia, Local Clinical Trial

Official title:
The Use of Electrical Stimulation for Determination of Epidural Catheter Placement

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06055686
Other study ID # 71662
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date January 2025

Study information
Verified date January 2024
Source Stanford University
Contact Ksenia Kasimova, MD
Phone 6507889458
Email kasimova@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to address the problem of epidural failure. The investigators 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. The investigators will use electrical stimulation to determine if the catheter moved in the sacral direction with insertion.

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 this 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, the investigators will perform electrical stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Lucile Packard Childrens Hospital Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence rate of sacral stimulation Electrical stimulation will be performed at incremental points during catheter pull back with documentation of where stimulation was seen. 1 year
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