Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04983511

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Following labor, epidural or combined spinal-epidural (CSE) catheters are kept in place and deactivated. However, many women opt for procedures such as tubal ligation, which may require epidural anesthesia as a method of pain relief. Our study aims to confirm the ability to predict reactivation of epidural catheter in postpartum females through the electrical epidural stimulation test (EST) which was first described by the PI of this study approximately 20 years ago.

Condition or Disease	Intervention/Treatment	Phase
Obstetric Pain Anesthesia, Local	Diagnostic Test: Electrical Epidural Stimulation Test (EST)	N/A

Detailed Description

In this study, investigators hope to investigate the ability of the electrical epidural stimulation test (EST) to predict reactivation of epidural catheter in postpartum females. The standard practice for confirming the reactivation of epidural or CSE catheters requires methods such as dosing the local anesthetic. With the EST test this will allow for the anesthesiologist to determine whether or not the epidural can be activated immediately.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients with deactivated epidural/CSE catheters will be given electrical epidural stimulation test to detect its ability to be reactivated.Patients with deactivated epidural/CSE catheters will be given electrical epidural stimulation test to detect its ability to be reactivated.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electrical Epidural Stimulation Test (EST) Postpartum women are given EST to predict epidural catheter reactivation for their subsequent procedures (i.e. tubal ligation).	Diagnostic Test: Electrical Epidural Stimulation Test (EST) EST measures sensory/motor responses

Arm

Intervention/Treatment

Experimental: Electrical Epidural Stimulation Test (EST)

Postpartum women are given EST to predict epidural catheter reactivation for their subsequent procedures (i.e. tubal ligation).

Diagnostic Test: Electrical Epidural Stimulation Test (EST)

EST measures sensory/motor responses

Outcome Measures

Primary Outcome Measures

Electrical Epidural Stimulation Test [Duration of EST test (approximately 1-2 hours)]
Investigate the ability of the electrical epidural stimulation test (EST) to predict epidural catheter reactivation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Females, 18 years and older
American Society of Anesthesiologists physical status I or II
Status post natural labor/birth process or C-section
Has epidural or CSE catheter
Upcoming procedure requiring epidural/CSE anesthesia for pain management

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
Did not receive epidural or CSE anesthesia

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University

ClinicalTrials.gov Identifier:

NCT04983511

Other Study ID Numbers:

61999

First Posted:

Jul 30, 2021

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University

Electrical Epidural Stimulation Test

Additional relevant MeSH terms:

Labor Pain

Study Results

No Results Posted as of Jul 25, 2022