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Utilizing Ultrasound for Residents as an Aid in Epidural Placement

NCT03378492 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-01-10

No results posted yet for this study

Summary

This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision.

Conditions

  • Epidural Placement

Interventions

DEVICE

Ultrasound Guided Epidural

Sterile ultrasound gel will be applied to the patient's back and the sterile device will be used to image the lumbar vertebrae in the area of the palpation-derived location. When the device is placed above the vertebral interspace, the 3D image mode will identify the spine midline and the depth from the skin to the epidural space. A single 3D ultrasound video loop of the vertebral interspace will be saved to confirm correct landmark identification. After identification of the vertebral interspace, the skin will be marked with a marking utensil or physical indentation at the point of needle entry indicated by the device. The epidural needle will then be placed in the same fashion as in the standard procedure group. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance.

PROCEDURE

Standard Epidural

The point of needle entry will be located using the landmarks technique. The specific level of epidural placement will be determined on a per-patient basis at the anesthesiologist's discretion. The spine midline will also be palpated to determine the approximate location of an interlaminar space. The needle will then be inserted at the appropriate location determined by the landmarks technique, and successful epidural placement will be confirmed by observation of loss of resistance and follow-up confirmation of analgesia. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance. The epidural catheter will be inserted and the procedure will continue according to the standard of care.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2019-11-30
Completion
2020-11-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378492 on ClinicalTrials.gov