Obstetric PainNCT04983511
Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population
A study testing Electrical Epidural Stimulation Test (EST) in people with Obstetric Pain and Anesthesia, Local, run by Stanford University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Pain, Anesthesia, Local
- What is being tested?
- Electrical Epidural Stimulation Test (EST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Obstetric Pain, Anesthesia, Local
- Being tested
- Electrical Epidural Stimulation Test (EST)
- Keywords
- Electrical Epidural Stimulation Test
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Epidural Stimulation Test (EST)Diagnostic test
EST measures sensory/motor responses
| Study group | Role | What they receive |
|---|---|---|
| Electrical Epidural Stimulation Test (EST) | Experimental | Postpartum women are given EST to predict epidural catheter reactivation for their subsequent procedures (i.e. tubal ligation). Receives: Diagnostic Test: Electrical Epidural Stimulation Test (EST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical Epidural Stimulation Test
Investigate the ability of the electrical epidural stimulation test (EST) to predict epidural catheter reactivation.
Measured: Duration of EST test (approximately 1-2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study startNov 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstetric PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Ho Ban Tsui, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983511
- Sponsor's protocol ID
- 61999
- Status last verified
- Apr 2025
- First submitted
- 20 Jul 2021
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25501494Delgado 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.
PubMed 30613393Tsui 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.
PubMed 9717595
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population
- ClinicalTrials.gov ID
- NCT04983511
- Acronym / sponsor ID
- 61999
- Conditions
- Obstetric Pain, Anesthesia, Local
- Keywords
- Electrical Epidural Stimulation Test
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with deactivated epidural/CSE catheters will be given electrical epidural stimulation test to detect its ability to be reactivated.
| Arm | Type | Receives |
|---|---|---|
| Electrical Epidural Stimulation Test (EST) | Experimental | Diagnostic Test: Electrical Epidural Stimulation Test (EST)Postpartum women are given EST to predict epidural catheter reactivation for their subsequent procedures (i.e. tubal ligation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Epidural Stimulation Test (EST)EST measures sensory/motor responses | Diagnostic test | Electrical Epidural Stimulation Test (EST) |
Primary outcome
Electrical Epidural Stimulation Test
Time frame: Duration of EST test (approximately 1-2 hours)
Investigate the ability of the electrical epidural stimulation test (EST) to predict epidural catheter reactivation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Results publication: PubMed 25501494Carvalho 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 publication: PubMed 30613393Delgado 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 publication: PubMed 9717595Tsui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Epidural Stimulation Test (EST) in people with Obstetric Pain and Anesthesia, Local, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ban C.H. Tsui, MD ((650) 200-9107, bantsui@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical Epidural Stimulation Test (time frame: Duration of EST test (approximately 1-2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04983511, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.