Obstetric Placement Study Using EST
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrical Epidural Stimulation Test (EST).
- Who it may be relevant to
- Registry conditions: Obstetric Pain, Anesthesia, Local. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Electrical Epidural Stimulation Test for Confirmation of Epidural Catheter Placement in Labouring Women
Overview
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.
Interventions
- Diagnostic test Electrical Epidural Stimulation Test (EST)
EST measures sensory/motor responses
Primary outcome measures
- Electrical Epidural Stimulation Test [Time frame: Duration of EST test (approximately 1-2 hours)]
Secondary outcome measures (1)
- Pain Scores [Time frame: Approximately 3 hours following introduction of anesthetics through the catheter.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Lucille Packard Children's Hospital — Palo Alto
Publications
- 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. PMID 25501494
Identifiers
NCT: NCT04109365 · 52856