Obesity, MorbidNCT03405311
3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient
A study testing Rivanna Accuro 3D Ultrasound Device and Palpation in people with Obesity, Morbid and Pregnancy, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity, Morbid, Pregnancy, Pain
- What is being tested?
- Rivanna Accuro 3D Ultrasound Device and Palpation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status class I, II, or III.
- Term pregnancy.
- Requesting epidural analgesia for anticipated vaginal delivery.
- BMI>or = 40.
Who cannot join
- Contraindication for epidural analgesia
- Inability to adequately understand the consent form.
- Incarcerated patients.
- Patients with known spinal deformities.
- Allergies to ultrasound gel.
- Allergies to local anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: 3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient: A Randomized Control Trial
This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device).
Read the detailed description
Worldwide obesity has become an epidemic. The obstetrical population is no exception. This made more challenging for anesthesiologists on labor and delivery units to administer epidural analgesia. According to the World Health Organization, more than 30% of U.S. adults are obese with a body mass index (BMI; in kg/m2) ≥ 30. Recent data has shown that increased BMI has been associated with increased neuraxial analgesic failure and difficulty with prolonged epidural placement time.
The 'Blind approach' is the current standard of care in administering neuraxial anesthesia. The physician palpates the patient's spinal bony landmarks; the needle is placed in relation to identified landmarks and inserted until loss of resistance is felt. In the obese population, the success rates are as low as 68%. Recently the FDA has approved a handheld device "The Accuro" as an adjunct for neuraxial analgesia (Rivanna Medical, LLC). It consists of a three-dimensional ultrasound device. By utilizing sound waves it constructs three-dimensional images of the spinal column, allowing the physician to better see the spine in order to perform spinal/epidural anesthesia.
Hypothesize that this device will enable clinicians to assess epidural spaces for epidural needle placement compared with the traditional Blind approach in the morbidly obese parturient.
This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device). Also, will determine if ultrasound based landmarks would reduce the needle tract and thereby reduced the amount of post-procedure pain at the insertion site in the peripartum period by using the algometer.
- Conditions
- Obesity, Morbid, Pregnancy, Pain
- Being tested
- Rivanna Accuro 3D Ultrasound Device, Palpation
- Keywords
- Labor analgesia, Ultrasound, Obesity, Morbid, Pregnancy, Labor Epidural Analgesia
- Medical subject headings
- Obesity, Morbid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivanna Accuro 3D Ultrasound DeviceDevice
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
PalpationOther
The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
| Study group | Role | What they receive |
|---|---|---|
| Palpation | Active comparator | The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode. Receives: Other: Palpation |
| Rivanna Accuro 3D Ultrasound Device | Experimental | The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device. Receives: Device: Rivanna Accuro 3D Ultrasound Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Needle Insertion Attempts Calculated Across All Participants
An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.
Measured: Beginning of needle insertion till catheter placement-15 minutes
Number of Participants With Successful Epidural Catheter Placements
Number of Participants With Successful Epidural Catheter Placements.
Measured: Within first 90 minutes following catheter placement
Number of Needle Insertion Redirections Calculated Across All Participants
An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.
Measured: Beginning of needle insertion till catheter placement-15 minutes
Secondary outcomes (4)
Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale
Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult).
Measured: Beginning of needle insertion till catheter placement-15 minutes
Needle Depth
We will also record thouy needle depth from skin and measured depth by ultrasound.
Measured: Beginning of needle insertion till catheter placement-15 minutes
Pressure Pain Thresholds
Pressure pain thresholds will be obtained immediately prior to the epidural placement using the pressure pain device.
Measured: Before epidural placement
Number of Complications Recorded Calculated Across All Participants
The number of complications related to the epidural recorded within 30 days of admission.
Measured: Within 30 days of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start20 Feb 2018
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Why it stopped: The study device is not working, and there is no funding available to purchase or rent a new one.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rovnat Babazade, MD, Principal investigator, The University of Texas Medical Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405311
- Sponsor's protocol ID
- 17-0286
- Status last verified
- Feb 2026
- First submitted
- 2 Jan 2018
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03405311
- Acronym / sponsor ID
- 17-0286
- Conditions
- Obesity, Morbid, Pregnancy, Pain
- Keywords
- Labor analgesia, Ultrasound, Obesity, Morbid, Pregnancy, Labor Epidural Analgesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study device is not working, and there is no funding available to purchase or rent a new one.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device).
Detailed description
Worldwide obesity has become an epidemic. The obstetrical population is no exception. This made more challenging for anesthesiologists on labor and delivery units to administer epidural analgesia. According to the World Health Organization, more than 30% of U.S. adults are obese with a body mass index (BMI; in kg/m2) ≥ 30. Recent data has shown that increased BMI has been associated with increased neuraxial analgesic failure and difficulty with prolonged epidural placement time.
The 'Blind approach' is the current standard of care in administering neuraxial anesthesia. The physician palpates the patient's spinal bony landmarks; the needle is placed in relation to identified landmarks and inserted until loss of resistance is felt. In the obese population, the success rates are as low as 68%. Recently the FDA has approved a handheld device "The Accuro" as an adjunct for neuraxial analgesia (Rivanna Medical, LLC). It consists of a three-dimensional ultrasound device. By utilizing sound waves it constructs three-dimensional images of the spinal column, allowing the physician to better see the spine in order to perform spinal/epidural anesthesia.
Hypothesize that this device will enable clinicians to assess epidural spaces for epidural needle placement compared with the traditional Blind approach in the morbidly obese parturient.
This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device). Also, will determine if ultrasound based landmarks would reduce the needle tract and thereby reduced the amount of post-procedure pain at the insertion site in the peripartum period by using the algometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpation | Active comparator | Other: PalpationThe control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode. |
| Rivanna Accuro 3D Ultrasound Device | Experimental | Device: Rivanna Accuro 3D Ultrasound DeviceThe treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists physical status class I, II, or III.
- Term pregnancy.
- Requesting epidural analgesia for anticipated vaginal delivery.
- BMI>or = 40.
Key exclusion criteria (6 listed)
- Contraindication for epidural analgesia
- Inability to adequately understand the consent form.
- Incarcerated patients.
- Patients with known spinal deformities.
- Allergies to ultrasound gel.
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 |
|---|---|---|
| Rivanna Accuro 3D Ultrasound DeviceThe treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device | Device | Rivanna Accuro 3D Ultrasound Device |
| PalpationThe control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode | Other | Palpation |
Primary outcome
Number of Needle Insertion Attempts Calculated Across All Participants
Time frame: Beginning of needle insertion till catheter placement-15 minutes
An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.
Number of Participants With Successful Epidural Catheter Placements
Time frame: Within first 90 minutes following catheter placement
Number of Participants With Successful Epidural Catheter Placements.
Number of Needle Insertion Redirections Calculated Across All Participants
Time frame: Beginning of needle insertion till catheter placement-15 minutes
An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.
4 secondary outcomes
Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale
Time frame: Beginning of needle insertion till catheter placement-15 minutes
Needle Depth
Time frame: Beginning of needle insertion till catheter placement-15 minutes
Pressure Pain Thresholds
Time frame: Before epidural placement
Number of Complications Recorded Calculated Across All Participants
Time frame: Within 30 days of admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 510(k) clearance for the Rivanna Accuro ultrasound deviceLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Rovnat Babazade, MD principal investigator
The University of Texas Medical Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rivanna Accuro 3D Ultrasound Device and Palpation in people with Obesity, Morbid and Pregnancy, run by The University of Texas Medical Branch, Galveston 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 4 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: stopped early, as of the sponsor's last update on 17 Feb 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?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Needle Insertion Attempts Calculated Across All Participants (time frame: Beginning of needle insertion till catheter placement-15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.