Obstetric Placement Study Using EST

Not Applicable

Recruiting

• Conditions: Anesthesia, Local; Obstetric Pain
• Interventions: Diagnostic Test: Electrical Epidural Stimulation Test (EST)

• Registration Number: NCT04109365
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Study Start: 2020-12-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Electrical Epidural Stimulation Test (EST)	Electrical Epidural Stimulation Test (EST)	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.

Primary Outcome Measures

Name	Time	Method
Electrical Epidural Stimulation Test	Duration of EST test (approximately 1-2 hours)	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.

Secondary Outcome Measures

Name	Time	Method
Pain Scores	Approximately 3 hours following introduction of anesthetics through the catheter.	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.

Trial Locations

Locations (1)

Lucille Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States