Obstetric Placement Study Using EST

Study Overview
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Brief Summary
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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.

Official Title
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Electrical Epidural Stimulation Test for Confirmation of Epidural Catheter Placement in Labouring Women

Conditions
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Obstetric Pain, Anesthesia, Local

Intervention / Treatment
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* Diagnostic Test: Electrical Epidural Stimulation Test (EST)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical Epidural Stimulation Test (EST)<br>Laboring women are given EST test initially before local anesthetic is administered and 1 hour post-anesthetic in order to measure sensory and motor responses. | Diagnostic Test: Electrical Epidural Stimulation Test (EST)<br>* EST measures sensory/motor responses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical Epidural Stimulation Test | Investigate the ability of the electrical epidural stimulation test (EST) to determine the position of the epidural catheter anesthesia for labour analgesia after low-dose anesthetic as compared to the gold standard of clinical assessment. | Duration of EST test (approximately 1-2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Patients will be asked for a pain score by research staff approximately 3 hours following placement of the epidural catheter and low-dose anesthetics are introduced. The pain scores will be on a scale from 0-10 with 0 representing no pain and 10 representing maximum pain. | Approximately 3 hours following introduction of anesthetics through the catheter. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Epidural Stimulation Test