Obstetric PainNCT06055686
The Use of Electrical Stimulation for Determination of Epidural Catheter Placement
A study testing Electrical Epidural Stimulation Test in people with Obstetric Pain and Anesthesia, Local, run by Stanford University at 1 site in United States.
Trial summary
The aim of this study is to address the problem of epidural failure. The investigators theorize epidural failure can be due to inappropriate catheter movement and this may be related to the length of which the epidural catheter is inserted. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obstetric Pain, Anesthesia, Local
- What is being tested?
- Electrical Epidural Stimulation Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to Nov 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant female requesting epidural for labor analgesia.
- Must meet standard inclusion criteria for safe epidural placement.
- Platelet count over 70,000, INR under 1.3.
Who cannot join
- Unable to safely place epidural catheter due to commonly accepted patient factors.
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
Lucile Packard Childrens Hospital
Stanford, California, 94305
About this study
The aim of this study is to address the problem of epidural failure. The investigators theorize epidural failure can be due to inappropriate catheter movement and this may be related to the length of which the epidural catheter is inserted. The investigators will use electrical stimulation to determine if the catheter moved in the sacral direction with insertion.
Read the detailed description
The research participants will be pregnant women in Labor and Delivery ward of Stanford University hospital who request an epidural for labor analgesia.
In this study the patients will receive an epidural catheter in the same way as standard of care. The catheter will be inserted to 20cm and then electrically stimulated to document where it is placed by looking at the muscles effected. The catheter is then pulled back in 5cm increments and stimulated until the standard distance is achieved. For example, if loss of resistance happened at 5cm, the catheter would be inserted to 20cm, stimulated, pulled back to 15cm and stimulated, and finally to 10cm and stimulated.
Electrical stimulation of epidural catheters for confirmation of placement is a published and accepted technique. In this study, the investigators will perform electrical stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.
- Conditions
- Obstetric Pain, Anesthesia, Local
- Being tested
- Electrical Epidural Stimulation Test
- Keywords
- Electrical Epidural Stimulation Test, Epidural Failure
- 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 TestDiagnostic test
Electrical stimulation test measures sensory/motor responses
| Study group | Role | What they receive |
|---|---|---|
| Electrical Epidural Stimulation Test | Experimental | Laboring women who request epidural analgesia will be given an electric stimulation at incremental points during catheter pull back with documentation of where stimulation was seen. Receives: Diagnostic Test: Electrical Epidural Stimulation Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of sacral stimulation
Electrical stimulation will be performed at incremental points during catheter pull back with documentation of where stimulation was seen.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 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
- Masking
- None (open label)
- Enrolment
- 50 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
- Investigators
- Steven Abboud, MD, Study director, Clinical Instructor, Anesthesiology, Perioperative and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055686
- Sponsor's protocol ID
- 71662
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kim YS, Kim HS, Jeong H, Lee CH, Lee MK, Choi SS. Efficacy of electrical stimulation on epidural anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2020 Jun 10;20(1):146. doi: 10.1186/s12871-020-01063-1.
PubMed 32522156Charghi R, Chan SY, Kardash KJ, Finlayson RJ, Tran DQ. Electrical stimulation of the epidural space using a catheter with a removable stylet. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):152-6. doi: 10.1016/j.rapm.2006.10.006.
PubMed 17350527Kwofie MK, Launcelott G, Tsui BCH. Determination of thoracic epidural catheter placement: electrical epidural stimulation (Tsui test) is simple, effective, and under-utilized. Can J Anaesth. 2019 Apr;66(4):360-364. doi: 10.1007/s12630-019-01302-1. Epub 2019 Jan 23. No abstract available.
PubMed 30675686
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
- The Use of Electrical Stimulation for Determination of Epidural Catheter Placement
- ClinicalTrials.gov ID
- NCT06055686
- Acronym / sponsor ID
- 71662
- Conditions
- Obstetric Pain, Anesthesia, Local
- Keywords
- Electrical Epidural Stimulation Test, Epidural Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Sep 2023 (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.
The aim of this study is to address the problem of epidural failure. The investigators theorize epidural failure can be due to inappropriate catheter movement and this may be related to the length of which the epidural catheter is inserted. The investigators will use electrical stimulation to determine if the catheter moved in the sacral direction with insertion.
Detailed description
The research participants will be pregnant women in Labor and Delivery ward of Stanford University hospital who request an epidural for labor analgesia.
In this study the patients will receive an epidural catheter in the same way as standard of care. The catheter will be inserted to 20cm and then electrically stimulated to document where it is placed by looking at the muscles effected. The catheter is then pulled back in 5cm increments and stimulated until the standard distance is achieved. For example, if loss of resistance happened at 5cm, the catheter would be inserted to 20cm, stimulated, pulled back to 15cm and stimulated, and finally to 10cm and stimulated.
Electrical stimulation of epidural catheters for confirmation of placement is a published and accepted technique. In this study, the investigators will perform electrical stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical Epidural Stimulation Test | Experimental | Diagnostic Test: Electrical Epidural Stimulation TestLaboring women who request epidural analgesia will be given an electric stimulation at incremental points during catheter pull back with documentation of where stimulation was seen. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant female requesting epidural for labor analgesia.
- Must meet standard inclusion criteria for safe epidural placement.
- Platelet count over 70,000, INR under 1.3.
Key exclusion criteria (1 listed)
- Unable to safely place epidural catheter due to commonly accepted patient factors.
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 TestElectrical stimulation test measures sensory/motor responses | Diagnostic test | Electrical Epidural Stimulation Test |
Primary outcome
Incidence rate of sacral stimulation
Time frame: 1 year
Electrical stimulation will be performed at incremental points during catheter pull back with documentation of where stimulation was seen.
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.
- Background: PubMed 32522156Kim YS, Kim HS, Jeong H, Lee CH, Lee MK, Choi SS. Efficacy of electrical stimulation on epidural anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2020 Jun 10;20(1):146. doi: 10.1186/s12871-020-01063-1.
- Background: PubMed 17350527Charghi R, Chan SY, Kardash KJ, Finlayson RJ, Tran DQ. Electrical stimulation of the epidural space using a catheter with a removable stylet. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):152-6. doi: 10.1016/j.rapm.2006.10.006.
- Background: PubMed 30675686Kwofie MK, Launcelott G, Tsui BCH. Determination of thoracic epidural catheter placement: electrical epidural stimulation (Tsui test) is simple, effective, and under-utilized. Can J Anaesth. 2019 Apr;66(4):360-364. doi: 10.1007/s12630-019-01302-1. Epub 2019 Jan 23. No abstract available.
- 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.
Steven Abboud, MD study director
Clinical Instructor, Anesthesiology, Perioperative and Pain Medicine
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 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 1 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.
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 Ksenia Kasimova, MD (6507889458, kasimova@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of sacral stimulation (time frame: 1 year). 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 NCT06055686, 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.