Labor AnalgesiaNCT05909085
The Impact of Needle Manipulation and Accuracy Between Hand Held Automatic and Traditional Ultrasound Device
A study testing Traditional ultrasound and Automated ultrasound in people with Labor Analgesia, run by Yale University at 1 site in United States.
Trial summary
In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Analgesia
- What is being tested?
- Traditional ultrasound and Automated ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to Dec 2027
- Phase
- Interventional
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA-1, ASA-2, and ASA-3
- Patients with no known back deformities
- Ability to sit upright for epidural placement
- No prior lumbar surgery
- No allergies to ultrasound gel
Who cannot join
- Coagulopathy
- Low platelet count
- Allergies to local anesthetics
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: A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices
In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.
Read the detailed description
Patient will be approached upon admission to labor and delivery floor (Standard of care). The study will be presented to the patient and if they agree, they will be consented. (Study). Upon epidural patient request patient will be randomized to A-US vs B-US based on the randomization table. Ten envelopes will be available with the randomization choice. (Study). The resident will walk in with both US devices into the room (for patient blinding) and perform scan with the device the randomization table called for. (Study). After performing scan and markings of the patients back, the research fellow or clinical fellow will be called into the room to evaluate the number of needle manipulation and provide surveys related to patient and labor analgesia satisfaction. (Study).
Number of needle insertion attempts: defined as advancement of the needle through the skin in an effort to enter the epidural space; a needle requiring withdrawal from the skin for reinsertion is to be counted as an additional insertion attempt. Time to landmark identification: defined as the time interval between the start of needle puncture site identification and the time to first needle puncture attempt. The start time of needle puncture site identification in both the LT and UST corresponds to when the resident physician first places his/her hand on the patient to palpate the back. In both groups, all materials, supplies, and equipment will be prepared and readily available prior to the start of the procedure.
- Conditions
- Labor Analgesia
- Being tested
- Traditional ultrasound, Automated ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ultrasoundDevice
Labor epidural will be performed after marking patient skin using traditional ultrasound guidance
Automated ultrasoundDevice
Labor epidural will be performed after marking patient skin using an automated ultrasound device
| Study group | Role | What they receive |
|---|---|---|
| Handheld traditional ultrasound | Active comparator | Traditional US will be used to compare number of needle manipulations to the handheld US. Receives: Device: Traditional ultrasound |
| Handheld Automated ultrasound | Other | Automated device provides automatic information pertaining to distance to epidural space distance and interspace location. Receives: Device: Automated ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of needle passes
Number of ventral needle movements without removing needle from skin. A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin.
Measured: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Secondary outcomes (7)
Number of Needle attempts
Number of times the needle is advanced in and out of the skin
Measured: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Time to obtain ultrasound images with traditional ultrasound device
Time from placing ultrasound on patients back until markings are complete
Measured: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Time to obtain images with automated ultrasound device
Time from placing ultrasound on patients back until markings are complete
Measured: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Time from local anesthetic injection till time of epidural space identification
Time will be recorded once local anesthetic is injected and stopped upon obtaining loss of resistance
Measured: Up to 60 minutes
Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance
Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.
Measured: Up to 60 minutes
Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance
Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.
Measured: Up to 60 minutes
Patient satisfaction
Assessed after the administration of the loading dose. Patient will be asked to rate their pain on a scale 0-10, 0 = not satisfied, 10 = completely satisfied
Measured: 15 - 20 minutes after epidural placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2027 (estimated)
- Primary completionDec 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 (4)Papers the sponsor has linked to this study.
- Other trials for Labor AnalgesiaStudies of the same condition, open and under way.
- More trials run by Yale 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Gonzalez, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909085
- Sponsor's protocol ID
- 2000034863
- Other IDs
- No NIH funding 09.05.23
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
PubMed 20696564Carvalho B, Seligman KM, Weiniger CF. The comparative accuracy of a handheld and console ultrasound device for neuraxial depth and landmark assessment. Int J Obstet Anesth. 2019 Aug;39:68-73. doi: 10.1016/j.ijoa.2019.01.004. Epub 2019 Jan 11.
PubMed 30770208Weiniger CF, Carvalho B, Ronel I, Greenberger C, Aptekman B, Almog O, Kagan G, Shalev S. A randomized trial to investigate needle redirections/re-insertions using a handheld ultrasound device versus traditional palpation for spinal anesthesia in obese women undergoing cesarean delivery. Int J Obstet Anesth. 2022 Feb;49:103229. doi: 10.1016/j.ijoa.2021.103229. Epub 2021 Sep 23.
PubMed 34670725Seligman KM, Weiniger CF, Carvalho B. The Accuracy of a Handheld Ultrasound Device for Neuraxial Depth and Landmark Assessment: A Prospective Cohort Trial. Anesth Analg. 2018 Jun;126(6):1995-1998. doi: 10.1213/ANE.0000000000002407.
PubMed 28858898