Influence of Lumbar Ultrasound on Resident Learning Curve for Lateral Labor Epidural Placement

September 27, 2024 updated by: Michaela Kristina Farber, MD, Brigham and Women's Hospital

Pre-insertion Ultrasound Guidance for Labor Epidural Placement in the Lateral Position: A Randomized Controlled Trial of Image Reproducibility During Labor and Impact on Resident Learning Curve

The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success rate and efficiency of labor epidural placement in the lateral position. The investigators hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield similar ultrasound results when done immediately prior to epidural placement. The investigators also hypothesize that the use of ultrasound with landmarks marked and depth to the epidural space estimated will facilitate epidural placement in terms of both efficiency (time required for placement) and efficacy of pain relief.

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

Several studies have demonstrated a significant benefit in pre-procedural ultrasound for epidural placement by anesthesia residents, particularly when performed in the obese population. To the investigators knowledge, however, no studies have evaluated this teaching modality for the lumber epidural technique in the lateral position. Formalizing the educational process for this less frequently performed, highly technical and critical skill may have a profound impact on trainee learning curves, and may enhance the overall success and efficiency of epidural placement, quality of analgesia provided, and safety of the procedure.

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.
28

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Pregnant Subjects

Inclusion Criteria:

  • pregnant women
  • 18 years or older
  • in early labor (cervix dilated < 5 cm
  • pain visual analog score (VAS) < 3, or both) requesting consultation by the anesthesia team for anticipated epidural pain relief.

Exclusion Criteria:

  • absolute contraindications of neuraxial anesthesia including patient refusal
  • uncorrected coagulopathy
  • infection at the skin site of epidural placement
  • increased intracranial pressure, or untreated hemodynamic instability.
  • In addition, patients with a history of scoliosis or spine surgery
  • body mass index (BMI) >40 kg/m2
  • allergy to local anesthetic, or allergy to opioids will be excluded.

Anesthesiologists

Inclusion criteria:

  • Anesthesia residents or fellows who are performing the epidural technique in pregnant subjects who agree to be part of the study.
  • Anesthesia residents or fellows with prior experience in the lumbar epidural technique, defined as having placed 20 or greater lumbar epidurals during their residency and prior to enrollment.

Exclusion criteria:

  • individuals who do not want to participate in the study.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
No Intervention: Control
Baseline ultrasound only, with no markings placed. No ultrasound prior to epidural placement.
Experimental: Ultrasound
Baseline and pre-puncture ultrasound with markings placed.
Other: Ultrasound
A baseline lumbar ultrasound in a standardized lateral position (by bed markings) will be performed with the midline and L3-L4 interspace marked, and estimated depth to the epidural space recorded. A second lateral lumbar ultrasound will be performed immediately prior to placement at the time of epidural request. The bed position will be standardized with lines drawn down the back, at the flexion of the knee, and heel of the foot. The sonographic measurements will include the midline, the L3-4 interspace, (both marked at the skin surface), and the measured depth to the ligamentum flavum (in centimeters).

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
Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound.
Time Frame: From enrollment to time of epidural placement, approximately 5 hours
Measured depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline, at level L3-4.
From enrollment to time of epidural placement, approximately 5 hours
Time required for epidural placement
Time Frame: From enrollment to time of epidural placement, approximately 5 hours
Time required for placement (T0 = insertion of needle for subcutaneous lidocaine infusion prior to epidural needle placement). Tfinal = time at complete removal of Weiss epidural needle after catheter is threaded into the epidural space.
From enrollment to time of epidural placement, approximately 5 hours
Need for assistance from additional anesthesiologist
Time Frame: From enrollment to time of epidural placement, approximately 5 hours
Need for assistance from additional anesthesiologist
From enrollment to time of epidural placement, approximately 5 hours
Number of attempts at epidural placement
Time Frame: From enrollment to time of epidural placement, approximately 5 hours
defined as number of times the Weiss epidural needle enters the skin
From enrollment to time of epidural placement, approximately 5 hours
Incidence of paresthesias
Time Frame: From enrollment to time of epidural placement, approximately 5 hours
Paresthesia defined as pain with needle or catheter insertion
From enrollment to time of epidural placement, approximately 5 hours
Labor pain at time of 30 minutes after placement is complete.
Time Frame: From enrollment to time of epidural placement, approximately 5 hours, plus 30 minutes.
Labor pain rated on a visual analog scale (VAS)
From enrollment to time of epidural placement, approximately 5 hours, plus 30 minutes.
Rate of epidural replacement for inadequate analgesia
Time Frame: From enrollment to time of epidural placement, approximately 5 hours
Inadequate analgesia determined as VAS >3 despite catheter adjustment and/or epidural dose adjustment.
From enrollment to time of epidural placement, approximately 5 hours
Rate of inadvertent dural puncture at the time of placement.
Time Frame: From enrollment to time of epidural placement, approximately 5 hours
Defined as cerebrospinal fluid aspiration through needle or catheter.
From enrollment to time of epidural placement, approximately 5 hours
Midline measurement from baseline ultrasound compared to pre-placement ultrasound.
Time Frame: From enrollment to time of epidural placement, approximately 5 hours
Measured midline (anatomical marking) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline.
From enrollment to time of epidural placement, approximately 5 hours
L3-L4 lumbar spine level measured from baseline ultrasound compared to pre-placement ultrasound.
Time Frame: From enrollment to time of epidural placement, approximately 5 hours
Measured L3-L4 lumbar spine level from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, paramedic.
From enrollment to time of epidural placement, approximately 5 hours

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.
Brigham and Women's Hospital

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: Michaela K Farber, MD MS, Brigham and Women's Hospital

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.

General Publications

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

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 1, 2014

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.
March 1, 2021

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.
March 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).
June 26, 2016

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.
July 7, 2016

First Posted (Estimated)

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.
July 11, 2016

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.
October 1, 2024

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 27, 2024

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, 2024

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.
  • 2013P002510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings