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

Primary Purpose

Obstetric Pain, Anesthesia, Local

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electrical Epidural Stimulation Test (EST)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstetric Pain focused on measuring Electrical Epidural Stimulation Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Electrical Epidural Stimulation Test (EST)

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Electrical Epidural Stimulation Test
    Investigate the ability of the electrical epidural stimulation test (EST) to predict epidural catheter reactivation.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 20, 2021
    Last Updated
    September 20, 2023
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04983511
    Brief Title
    Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population
    Official Title
    Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2024 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstetric Pain, Anesthesia, Local
    Keywords
    Electrical Epidural Stimulation Test

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Patients with deactivated epidural/CSE catheters will be given electrical epidural stimulation test to detect its ability to be reactivated.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Electrical Epidural Stimulation Test (EST)
    Arm Type
    Experimental
    Arm Description
    Postpartum women are given EST to predict epidural catheter reactivation for their subsequent procedures (i.e. tubal ligation).
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Electrical Epidural Stimulation Test (EST)
    Intervention Description
    EST measures sensory/motor responses
    Primary Outcome Measure Information:
    Title
    Electrical Epidural Stimulation Test
    Description
    Investigate the ability of the electrical epidural stimulation test (EST) to predict epidural catheter reactivation.
    Time Frame
    Duration of EST test (approximately 1-2 hours)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ban C.H. Tsui, MD
    Phone
    (650) 200-9107
    Email
    bantsui@stanford.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ksenia Kasimova, MD
    Phone
    (650) 788-9458
    Email
    kasimova@stanford.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25501494
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    30613393
    Citation
    Delgado C, Van Cleve W, Kent C, Dinges E, Bollag LA. Neuraxial anesthesia for postpartum tubal ligation at an academic medical center. F1000Res. 2018 Sep 26;7:1557. doi: 10.12688/f1000research.16025.1. eCollection 2018.
    Results Reference
    result
    PubMed Identifier
    9717595
    Citation
    Tsui BC, Gupta S, Finucane B. Confirmation of epidural catheter placement using nerve stimulation. Can J Anaesth. 1998 Jul;45(7):640-4. doi: 10.1007/BF03012093.
    Results Reference
    result

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

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