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The Use of Ultrasound to Measure Depth of Thoracic Epidural Space

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ClinicalTrials.gov Identifier: NCT01172730
Recruitment Status : Completed
First Posted : July 30, 2010
Last Update Posted : April 11, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Post Operative Trauma Acute Pain Device: Ultrasound scanning

Study Design

Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Ultrasound to Measure Depth of Thoracic Epidural Space Compared With Blind Technique
Study Start Date : May 2010
Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. The success rate of epidural catheter to control pain [ Time Frame: post operative day # 1 ]

Secondary Outcome Measures :
  1. The complication rate from epidural catheter placement. [ Time Frame: Immediate complications 24 hrs after ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having a thoracic epidural catheter for post operative pain

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172730

United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Principal Investigator: Issam Khayata, MD University of Massachusetts, Worcester
More Information

Responsible Party: Issam Khayata, Study Principle Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01172730     History of Changes
Other Study ID Numbers: 13495
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by Issam Khayata, University of Massachusetts, Worcester:
Post operative pain
thoracic epidural
acute pain
Ultrasound scanning of the thoracic spine

Additional relevant MeSH terms:
Acute Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms