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The Use of Ultrasound to Measure Depth of Thoracic Epidural Space

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01172730
First Posted: July 30, 2010
Last Update Posted: April 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Issam Khayata, University of Massachusetts, Worcester
  Purpose

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 Intervention
Post Operative Trauma Acute Pain Device: Ultrasound scanning

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Ultrasound to Measure Depth of Thoracic Epidural Space Compared With Blind Technique

Resource links provided by NLM:


Further study details as provided by Issam Khayata, University of Massachusetts, Worcester:

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

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

Enrollment: 29
Study Start Date: May 2010
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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


Locations
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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 Submitted: May 24, 2010
First Posted: July 30, 2010
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
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms