The Use of Ultrasound to Measure Depth of Thoracic Epidural Space

April 9, 2013 updated by: Issam Khayata, University of Massachusetts, Worcester

Use of Ultrasound to Measure Depth of Thoracic Epidural Space Compared With Blind Technique

The purpose of the study is to evaluate the use of ultrasound scanning of the thoracic spine to define the point of insertion and the depth of the epidural space compared to the blind technique.

The study hypothesis is the use of Ultrasound will improve the success rate of epidural placement and may also decrease the rate of complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

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
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having a thoracic epidural catheter for post operative pain

Description

Inclusion Criteria:

  • Patients 18 years and older having a thoracic epidural catheter
  • Both male and female patients.

Exclusion Criteria:

  • Pediatric population < 18 years of age
  • Pregnancy
  • Prisoners
  • Absolute Contraindication to thoracic epidural placement severe scoliosis or deformity,
  • Patients with previous spine surgery or hardware implanted at level of epidural placement,
  • Anticipated ventilation postoperatively for a period more that 24 hrs
  • Lack of patient consent to enroll 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasound scanning
Device: Ultrasound scanning
Ultrasound scanning is used to define needle insertion point and depth of epidural space.
Other Names:
  • LogicE GE portable ultrasound machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The success rate of epidural catheter to control pain
Time Frame: post operative day # 1
post operative day # 1

Secondary Outcome Measures

Outcome Measure
Time Frame
The complication rate from epidural catheter placement.
Time Frame: Immediate complications 24 hrs after
Immediate complications 24 hrs after

Collaborators and Investigators

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

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Issam Khayata, MD, University of Massachusetts, Worcester

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

May 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (Estimate)

July 30, 2010

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13495

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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