Clinical trial NCT04983511: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstetric Pain
Anesthesia, Local
Keywords: Electrical Epidural Stimulation Test
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with deactivated epidural/CSE catheters will be given electrical epidural stimulation test to detect its ability to be reactivated.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Electrical Epidural Stimulation Test
timeFrame: Duration of EST test (approximately 1-2 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.