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Not yet recruiting NCT04983511

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

No phase Interventional Obstetric Pain Anesthesia, Local

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical Epidural Stimulation Test (EST).
Who it may be relevant to
Registry conditions: Obstetric Pain, Anesthesia, Local. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Electrical Epidural Stimulation Test [Time frame: Duration of EST test (approximately 1-2 hours)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 25501494
  • 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. PMID 30613393
  • 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. PMID 9717595

Identifiers

NCT: NCT04983511 · 61999

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗