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The Use of Ultrasound to Measure Depth of Thoracic Epidural Space

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Issam Khayata, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01172730
First received: May 24, 2010
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

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

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

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Issam Khayata, Study Principle Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01172730     History of Changes
Other Study ID Numbers: 13495
Study First Received: May 24, 2010
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013