Obstetric PainNCT04109365
Obstetric Placement Study Using EST
A study testing Electrical Epidural Stimulation Test (EST) in people with Obstetric Pain and Anesthesia, Local, run by Stanford University at 1 site in United States.
Trial summary
Combined spinal-epidural (CSE) is an established technique for providing labour analgesia to obstetric patients which provides rapid onset but unsustained analgesia. The epidural catheter can be used to extend and provide continuous pain relief, however during single-segment needle-through-needle CSE, the catheter is… 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
- 1 siteUnited States
- Study dates
- 15 Dec 2020to Dec 2025
- 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
- Full-term pregnancy with request for epidural early in labour (i.e. Regular labor or C-Section)
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lucille Packard Children's Hospital
Palo Alto, California, 94304
Ban Tsui, MD, 650-200-9107, bantsui@stanford.edu
About this study
Official title: Electrical Epidural Stimulation Test for Confirmation of Epidural Catheter Placement in Labouring Women
Combined spinal-epidural (CSE) is an established technique for providing labour analgesia to obstetric patients which provides rapid onset but unsustained analgesia. The epidural catheter can be used to extend and provide continuous pain relief, however during single-segment needle-through-needle CSE, the catheter is untested. This study aims to confirm placement of epidural catheters of anesthesia through the epidural stimulation test (EST) which was first described by the PI of the study for confirming placement of epidural catheters approximately 20 years ago.
- 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 | Laboring women are given EST test initially before local anesthetic is administered and 1 hour post-anesthetic in order to measure sensory and motor responses. 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 determine the position of the epidural catheter anesthesia for labour analgesia after low-dose anesthetic as compared to the gold standard of clinical assessment.
Measured: Duration of EST test (approximately 1-2 hours)
Secondary outcomes (1)
Pain Scores
Patients will be asked for a pain score by research staff approximately 3 hours following placement of the epidural catheter and low-dose anesthetics are introduced. The pain scores will be on a scale from 0-10 with 0 representing no pain and 10 representing maximum pain.
Measured: Approximately 3 hours following introduction of anesthetics through the catheter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start15 Dec 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Sequential
- 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
- NCT04109365
- Sponsor's protocol ID
- 52856
- Status last verified
- Apr 2025
- First submitted
- 11 Sep 2019
- 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 25501494
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 Confirmation of Epidural Catheter Placement in Labouring Women
- ClinicalTrials.gov ID
- NCT04109365
- Acronym / sponsor ID
- 52856
- Conditions
- Obstetric Pain, Anesthesia, Local
- Keywords
- Electrical Epidural Stimulation Test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Sep 2019 (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.
Combined spinal-epidural (CSE) is an established technique for providing labour analgesia to obstetric patients which provides rapid onset but unsustained analgesia. The epidural catheter can be used to extend and provide continuous pain relief, however during single-segment needle-through-needle CSE, the catheter is untested. This study aims to confirm placement of epidural catheters of anesthesia through the epidural stimulation test (EST) which was first described by the PI of the study for confirming placement of epidural catheters approximately 20 years ago.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical Epidural Stimulation Test (EST) | Experimental | Diagnostic Test: Electrical Epidural Stimulation Test (EST)Laboring women are given EST test initially before local anesthetic is administered and 1 hour post-anesthetic in order to measure sensory and motor responses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females, 18 years and older
- American Society of Anesthesiologists physical status I or II
- Full-term pregnancy with request for epidural early in labour (i.e. Regular labor or C-Section)
Key exclusion criteria (6 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 determine the position of the epidural catheter anesthesia for labour analgesia after low-dose anesthetic as compared to the gold standard of clinical assessment.
1 secondary outcome
Pain Scores
Time frame: Approximately 3 hours following introduction of anesthetics through the catheter.
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.
- 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.
1 site in 1 country: see every site and its status.
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 at 1 site in United States.
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 3 inclusion and 6 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: looking for participants now, 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chynna Villanueva, BS, RN (6504986346, chynnav@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 NCT04109365, which also lists 1 linked publication.
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.