Labor PainNCT06281249
Neuraxial Ultrasound Device Study
A study testing Ultrasound placement device in people with Labor Pain and Cesarean Delivery Regional Anesthesia Induction, run by Stanford University at 1 site in United States.
Trial summary
The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Labor Pain, Cesarean Delivery Regional Anesthesia Induction
- What is being tested?
- Ultrasound placement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2026to Dec 2027
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- The patient is eligible for placement of neuraxial anesthesia, and the patient has agreed to the procedure.
- Patient skin is intact in the area of placement of the epidural or spinal anesthesia.
Who cannot join
- Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 70,000/μL, or evidence of infection at potential epidural site.
- Presence of orthopedic implants in the spine.
- Skin dyscrasias or allergies to the ultrasound procedure.
- Unable to assume sitting position.
- Body Mass Index (BMI) less than 20 kg/m2.
- Known allergies to ultrasound gel.
- Known history of allergic reactions to adhesives used in standard epidural placement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Real-time Spine Ultrasound Imaging System: Data Collection Study
The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.
Read the detailed description
This is a prospective, structured observational study (data collection study) in which Investigators enroll patients who are scheduled for neuraxial anesthesia procedures.
Qualified subjects will be identified and contacted by the anesthesia team prior to their clinical evaluation for labor neuraxial analgesia. Potential patients will be informed of the study, and if study individuals choose to participate and an informed consent form will be signed prior to any study related activities.
When study participants request labor analgesia, investigators will incorporate routine care delivery flow for patients receiving ultrasound guided neuraxial anesthesia.
The clinician will apply ultrasound gel to the Accuro 3S probe (gel inside the probe need not be sterile), and then cover the probe in a sterile probe cover. Sterile ultrasound gel will then be applied to the patient's skin on the back to enable imaging. The Accuro 3S probe will be applied to the patient's spinal region and the clinician will perform scouting scans. Image recordings can be captured by depressing a button located on the probe handle. While performing the scouting scans, the provider will take several image recordings of the spine. The image recordings will include two levels, finding the space, and then at each level plus a spinous process, scanning left and right at each of these points.
The clinician will then administer local anesthetic prior to needle procedures. After needle insertion point and trajectory is established on the ultrasound image, the epidural or spinal needle will then be advanced by the clinician based on their standard technique. While advancing the needle the provider will collect a series of image recordings.
After proper placement of needle/catheter, the Accuro 3S device will then be removed from the patient and they will proceed with standard clinical protocol for post placement care.
Accuro 3S: Primary data collected during this study will be images recordings captured during the scouting and needle placement for the epidural procedure. Images will be acquired directly on the 3S and will not contain patient identifiers.
After collection of data up to 100 patients, Investigators will be moving to clinical analysis.
Rivanna is the sponsor and will be funding this research. The de-identified patient data that Rivanna will receive for analysis include: results of demographic information (e.g. age, height, weight, sex, race, and ethnicity). Obstetric details including gravity, parity, gestational age, labor or cesarean delivery, pain score prior to and after placement. Accuro 3S Images (including scouting images of spine and images of needle placement). Insertion: Number of needle passes and redirects, interspace attempted/inserted; epidural or spinal, and needle gauges used. Number, type, and details of any complication (e.g. wet tap). Failed spinal or epidural including: pain >3/10 after labor epidural, catheter replacement, no or one-sided sensory block, failure to provide cesarean anesthesia, conversion to different type of anesthesia.
Patients will undergo their standard medical and obstetric treatment at the discretion of the obstetrical and anesthesia team. There will be no delay in their treatment due to this study, and the device data will not be available of influence care.
- Being tested
- Ultrasound placement device
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound placement deviceDevice
Also called Accuro 3S
Device to assist in placement of epidural procedure
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal neuraxial procedure | Experimental | Participants undergoing surgery, receiving neuraxial intrathecal anesthesia with block placement in part by the investigational device. Receives: Device: Ultrasound placement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of difficult block placement
Difficult block placement is defined by need of > 2 needle insertion attempts for succesful neuraxial analgesia/anesthesia
Measured: 15 minutes
Secondary outcomes (2)
Incidence of failed block
Failed labor epidural analgesia and spinal anesthesia will be defined by presence of 1 or more of the following conditions: one-sided or no sensory block, pain >3/10 after epidural placement, epidural replacement, conversion to a different form of anesthesia)
Measured: 30 minutes
Incidence of post-dural puncture headache
Headache developing within 7 days post block placement defined by presence of at least one of the following symptoms: posture dependent headache, symmetric headache posture dependent, neck pain posture dependent
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Dec 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Labor 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Rivanna Medical, Inc.
- Responsible party
- Principal investigator, Clemens Ortner, Stanford University
- Investigators
- Clemens Ortner, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281249
- Sponsor's protocol ID
- 73172
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Boselli E, Hopkins P, Lamperti M, Estebe JP, Fuzier R, Biasucci DG, Disma N, Pittiruti M, Traskaite V, Macas A, Breschan C, Vailati D, Subert M. European Society of Anaesthesiology and Intensive Care Guidelines on peri-operative use of ultrasound for regional anaesthesia (PERSEUS regional anesthesia): Peripheral nerves blocks and neuraxial anaesthesia. Eur J Anaesthesiol. 2021 Mar 1;38(3):219-250. doi: 10.1097/EJA.0000000000001383.
PubMed 33186303Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
PubMed 26580836Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24.
PubMed 33642943Rajagopalan S, Shah K, Guffey D, Tran C, Suresh M, Wali A. Predictors of difficult epidural placement in pregnant women: A trainees' perspective. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):548-552. doi: 10.4103/joacp.JOACP_340_18.
PubMed 31920244Ismail S, Raza A, Munshi K, Tabassum R. Failure rate of labor epidural: An observational study among different levels of trainee anesthesiologists in a university hospital of a developing country. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):210-215. doi: 10.4103/joacp.JOACP_39_19. Epub 2021 Jul 15.
PubMed 34349368Cittadini G, Martinoli C. [Ultrasound and the bone: a difficult relationship]. Radiol Med. 1995 Jan-Feb;89(1-2):12-7. Italian.
PubMed 7716291Mao Q, He H, Lu Y, Hu Y, Wang Z, Gan M, Yan H, Chen L. Ultrasound probe tilt impedes the needle-beam alignment during the ultrasound-guided procedures. Sci Rep. 2021 Jan 15;11(1):1599. doi: 10.1038/s41598-021-81354-w.
PubMed 33452406Tiouririne M, Dixon AJ, Mauldin FW Jr, Scalzo D, Krishnaraj A. Imaging Performance of a Handheld Ultrasound System With Real-Time Computer-Aided Detection of Lumbar Spine Anatomy: A Feasibility Study. Invest Radiol. 2017 Aug;52(8):447-455. doi: 10.1097/RLI.0000000000000361.
PubMed 28230717
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Spine Ultrasound Imaging System: Data Collection Study
- ClinicalTrials.gov ID
- NCT06281249
- Acronym / sponsor ID
- 73172
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Rivanna Medical, Inc.
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Feb 2024 (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 the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.
Detailed description
This is a prospective, structured observational study (data collection study) in which Investigators enroll patients who are scheduled for neuraxial anesthesia procedures.
Qualified subjects will be identified and contacted by the anesthesia team prior to their clinical evaluation for labor neuraxial analgesia. Potential patients will be informed of the study, and if study individuals choose to participate and an informed consent form will be signed prior to any study related activities.
When study participants request labor analgesia, investigators will incorporate routine care delivery flow for patients receiving ultrasound guided neuraxial anesthesia.
The clinician will apply ultrasound gel to the Accuro 3S probe (gel inside the probe need not be sterile), and then cover the probe in a sterile probe cover. Sterile ultrasound gel will then be applied to the patient's skin on the back to enable imaging. The Accuro 3S probe will be applied to the patient's spinal region and the clinician will perform scouting scans. Image recordings can be captured by depressing a button located on the probe handle. While performing the scouting scans, the provider will take several image recordings of the spine. The image recordings will include two levels, finding the space, and then at each level plus a spinous process, scanning left and right at each of these points.
The clinician will then administer local anesthetic prior to needle procedures. After needle insertion point and trajectory is established on the ultrasound image, the epidural or spinal needle will then be advanced by the clinician based on their standard technique. While advancing the needle the provider will collect a series of image recordings.
After proper placement of needle/catheter, the Accuro 3S device will then be removed from the patient and they will proceed with standard clinical protocol for post placement care.
Accuro 3S: Primary data collected during this study will be images recordings captured during the scouting and needle placement for the epidural procedure. Images will be acquired directly on the 3S and will not contain patient identifiers.
After collection of data up to 100 patients, Investigators will be moving to clinical analysis.
Rivanna is the sponsor and will be funding this research. The de-identified patient data that Rivanna will receive for analysis include: results of demographic information (e.g. age, height, weight, sex, race, and ethnicity). Obstetric details including gravity, parity, gestational age, labor or cesarean delivery, pain score prior to and after placement. Accuro 3S Images (including scouting images of spine and images of needle placement). Insertion: Number of needle passes and redirects, interspace attempted/inserted; epidural or spinal, and needle gauges used. Number, type, and details of any complication (e.g. wet tap). Failed spinal or epidural including: pain >3/10 after labor epidural, catheter replacement, no or one-sided sensory block, failure to provide cesarean anesthesia, conversion to different type of anesthesia.
Patients will undergo their standard medical and obstetric treatment at the discretion of the obstetrical and anesthesia team. There will be no delay in their treatment due to this study, and the device data will not be available of influence care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrathecal neuraxial procedure | Experimental | Device: Ultrasound placement deviceParticipants undergoing surgery, receiving neuraxial intrathecal anesthesia with block placement in part by the investigational device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- The patient is eligible for placement of neuraxial anesthesia, and the patient has agreed to the procedure.
- Patient skin is intact in the area of placement of the epidural or spinal anesthesia.
Key exclusion criteria (7 listed)
- Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 70,000/μL, or evidence of infection at potential epidural site.
- Presence of orthopedic implants in the spine.
- Skin dyscrasias or allergies to the ultrasound procedure.
- Unable to assume sitting position.
- Body Mass Index (BMI) less than 20 kg/m2.
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 |
|---|---|---|
| Ultrasound placement deviceAlso: Accuro 3SDevice to assist in placement of epidural procedure | Device | Intrathecal neuraxial procedure |
Primary outcome
Incidence of difficult block placement
Time frame: 15 minutes
Difficult block placement is defined by need of > 2 needle insertion attempts for succesful neuraxial analgesia/anesthesia
2 secondary outcomes
Incidence of failed block
Time frame: 30 minutes
Incidence of post-dural puncture headache
Time frame: 7 days
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 24 Apr 2026.
- Background: PubMed 33186303Boselli E, Hopkins P, Lamperti M, Estebe JP, Fuzier R, Biasucci DG, Disma N, Pittiruti M, Traskaite V, Macas A, Breschan C, Vailati D, Subert M. European Society of Anaesthesiology and Intensive Care Guidelines on peri-operative use of ultrasound for regional anaesthesia (PERSEUS regional anesthesia): Peripheral nerves blocks and neuraxial anaesthesia. Eur J Anaesthesiol. 2021 Mar 1;38(3):219-250. doi: 10.1097/EJA.0000000000001383.
- Background: PubMed 26580836Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
- Background: PubMed 33642943Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24.
- Background: PubMed 31920244Rajagopalan S, Shah K, Guffey D, Tran C, Suresh M, Wali A. Predictors of difficult epidural placement in pregnant women: A trainees' perspective. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):548-552. doi: 10.4103/joacp.JOACP_340_18.
- Background: PubMed 34349368Ismail S, Raza A, Munshi K, Tabassum R. Failure rate of labor epidural: An observational study among different levels of trainee anesthesiologists in a university hospital of a developing country. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):210-215. doi: 10.4103/joacp.JOACP_39_19. Epub 2021 Jul 15.
- Background: PubMed 7716291Cittadini G, Martinoli C. [Ultrasound and the bone: a difficult relationship]. Radiol Med. 1995 Jan-Feb;89(1-2):12-7. Italian.
- Background: PubMed 33452406Mao Q, He H, Lu Y, Hu Y, Wang Z, Gan M, Yan H, Chen L. Ultrasound probe tilt impedes the needle-beam alignment during the ultrasound-guided procedures. Sci Rep. 2021 Jan 15;11(1):1599. doi: 10.1038/s41598-021-81354-w.
- Background: PubMed 28230717Tiouririne M, Dixon AJ, Mauldin FW Jr, Scalzo D, Krishnaraj A. Imaging Performance of a Handheld Ultrasound System With Real-Time Computer-Aided Detection of Lumbar Spine Anatomy: A Feasibility Study. Invest Radiol. 2017 Aug;52(8):447-455. doi: 10.1097/RLI.0000000000000361.
- 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.
Clemens Ortner, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound placement device in people with Labor Pain and Cesarean Delivery Regional Anesthesia Induction, 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 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 24 Apr 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of difficult block placement (time frame: 15 minutes). 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 NCT06281249, which also lists 8 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 24 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.