3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient

February 12, 2026 updated by: The University of Texas Medical Branch, Galveston

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status class I, II, or III.
  • Term pregnancy.
  • Requesting epidural analgesia for anticipated vaginal delivery.
  • BMI>or = 40.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Palpation
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.
Other: Palpation
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
Experimental: Rivanna Accuro 3D Ultrasound Device
The 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
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Beginning of needle insertion till catheter placement-15 minutes
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.
Within first 90 minutes following catheter placement
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.
Beginning of needle insertion till catheter placement-15 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale
Time Frame: Beginning of needle insertion till catheter placement-15 minutes
Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult).
Beginning of needle insertion till catheter placement-15 minutes
Needle Depth
Time Frame: Beginning of needle insertion till catheter placement-15 minutes
We will also record thouy needle depth from skin and measured depth by ultrasound.
Beginning of needle insertion till catheter placement-15 minutes
Pressure Pain Thresholds
Time Frame: Before epidural placement
Pressure pain thresholds will be obtained immediately prior to the epidural placement using the pressure pain device.
Before epidural placement
Number of Complications Recorded Calculated Across All Participants
Time Frame: Within 30 days of admission
The number of complications related to the epidural recorded within 30 days of admission.
Within 30 days of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rovnat Babazade, MD, The University of Texas Medical Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-0286

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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