Clinical trial NCT06055686: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstetric Pain
Anesthesia, Local
Keywords: Electrical Epidural Stimulation Test
Epidural Failure
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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 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.

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.

Primary outcomes:
measure: Incidence rate of sacral stimulation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Childrens Hospital
state: California
Study officials:
affiliation: Clinical Instructor, Anesthesiology, Perioperative and Pain Medicine
name: Steven Abboud, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.