Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients

September 8, 2021 updated by: Mark Powell, University of Alabama at Birmingham

Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients: A Randomized, Prospective Study

This study will address the utility of ultrasound in the placement of an epidural catheter in severely obese parturients. Identification of midline can often be difficult using the standard method of palpation in obese patients. The Investigator will determine if the use of ultrasound decreases the amount of time and number of attempts required to place the epidural.

Study Overview

Status

Status

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

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

The use of ultrasound has expanded into many areas of medicine including the identification of bony landmarks to facilitate epidural placement in obstetric anesthesia. Using ultrasound for epidural placement has become popular over the last decade with several studies being published on the topic. The likely increase in popularity for ultrasound use in the obstetric population is the need to more reliably locate bony landmarks as the traditional palpation technique has been shown to be an inaccurate way to accomplish this. Given the fact that the long-taught palpation technique can be inaccurate and studies have validated the use of ultrasound for epidural placement, ultrasound technique is routinely taught by the obstetric anesthesiologists to the anesthesiology residents at the University of Alabama at Birmingham (UAB). Also, since both techniques are considered standard practice at UAB, anesthesia providers (residents, fellows, and faculty) are free to choose either technique to locate bony structures of the back prior to epidural placement. Since no current study has specifically addressed its use in the obese pregnant patient, the investigators would like to validate its use in this population.

In this study, investigators will evaluate the use of ultrasound in the obese population to determine if its use will decrease the time it takes to place the epidural and number of attempts required when compared to the traditional palpation technique. The study will also determine the success rate of epidural placement in both the palpation and ultrasound groups.

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.
150

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 Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • UAB Department of Anesthesiology and Perioperative Medicine

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

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patient request for a labor epidural
  • BMI≥35

Exclusion Criteria:

  • BMI<35
  • patient refusal of a labor epidural
  • coagulopathy
  • platelets<80,000
  • prior spine procedure or instrumentation
  • a diagnosis of scoliosis
  • an intracranial or spinal mass

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: None (Open Label)

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 Group
The palpation group will have an epidural placed after manual palpation of the spine.
Procedure: Palpation
Traditional epidural methods used for the identification of the midline using palpation prior to procedure
Active Comparator: Ultrasound Group
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Device: Ultrasound
Lumbar spinal ultrasound performed for identification of the midline prior to procedure.

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
Time for Epidural Placement
Time Frame: Baseline up to 1 hour
Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.
Baseline up to 1 hour
Number of Needle Passes
Time Frame: Baseline up to 1 hour
Baseline up to 1 hour
Total Time
Time Frame: Baseline up to 1 hour
Baseline up to 1 hour

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
Time to Identify Midline
Time Frame: Baseline up to 1 hour
Comparing the time it takes to locate midline of the back in the palpation group vs. the ultrasound group. Measured in minutes from the start of the identification process until completion of the midline identification process.
Baseline up to 1 hour
Epidural Failure Rate
Time Frame: Baseline up to 1 hour
Comparing the number of epidural failures in the palpation vs. ultrasound group.
Baseline up to 1 hour
Number of Top-offs Required
Time Frame: Baseline up to 1 hour
Baseline up to 1 hour

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.
University of Alabama at Birmingham

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.
June 22, 2015

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.
October 1, 2018

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.
September 1, 2021

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).
March 25, 2017

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.
March 29, 2017

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.
April 4, 2017

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.
September 29, 2021

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.
September 8, 2021

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.
September 1, 2021

More Information

Terms related to this study

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.
  • F150402002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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