Obstetric Placement Study Using EST

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109365
• Other study ID #: 52856
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: Chynna Villanueva, BS, RN
• Phone: 6504986346
• Email: chynnav[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Labor Pain
• Obstetric Pain

Intervention

Diagnostic Test:
• Electrical Epidural Stimulation Test (EST)
EST measures sensory/motor responses

Locations

Country	Name	City	State
United States	Lucille Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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;6 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.