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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04983511
Other study ID # 61999
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 2024

Study information

Verified date September 2023
Source Stanford University
Contact Ban C.H. Tsui, MD
Phone (650) 200-9107
Email bantsui@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date December 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

References & Publications (3)

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

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. — View 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. — 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 predict epidural catheter reactivation. Duration of EST test (approximately 1-2 hours)
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