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Ultrasound-Guided Technique for Thoracic Epidural Insertion

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.
ClinicalTrials.gov Identifier: NCT01449214
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary:
Thoracic epidural analgesia and anesthesia are effective in improving the quality of intraoperative and postoperative pain relief during thoracic and abdominal surgical procedures. Conventional epidural techniques have significant limitations. Due to the anatomic characteristics of the thoracic versus the lumbar intervertebral spaces, the insertion requires a more technically challenging paramedian approach. The safety and feasibility of bedside ultrasonography for the lumbar spine has already been established and it proves to be a valuable tool for neuraxial anesthesia in obstetric anesthesia

Condition or disease Intervention/treatment
Pain Procedure: Ultrasound Procedure: Landmarking

Detailed Description:
• The feasibility and the reliability of US imaging for the thoracic spine has been proven by comparing the findings of ultrasound scans to MRI measurements, which is the standard imaging technique for the depiction of the spine. Pre-puncture US assessment may contribute to the safety and efficacy of the thoracic epidural technique. The purpose of this study is to compare the ultrasound-guided thoracic epidural insertion technique with the conventional anatomic landmarking technique of contacting bone and walking-off the lamina

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Technique for Thoracic Epidural Insertion: A Randomized Controlled Trial
Study Start Date : October 2011
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ultrasound
Use of ultrasound to identify interlaminar spaces for needle insertion. Intervention/Procedure: ultrasound-guided technique.
Procedure: Ultrasound
Ultrasound-guided technique
Active Comparator: Landmarking
Use of manual palpation to identify anatomic landmarks for needle insertion. Procedure/Intervention: landmark-guided technique.
Procedure: Landmarking
Landmark-guided technique

Primary Outcome Measures :
  1. Needle redirections [ Time Frame: 30 minutes ]
    Number of needle redirections defined as the need to withdraw the epidural needle for the purpose of continuing on a different angle (sagittal or axial plane)

Secondary Outcome Measures :
  1. Bony contacts [ Time Frame: 30 minutes ]
    number of bony contacts during the needle insertion

  2. New insertion point [ Time Frame: 30 minutes ]
    need to re-insert the epidural needle in the same interlaminar space, but using different insertion point

  3. Number of insertions [ Time Frame: 30 minutes ]
    number of different interlaminar space insertions

  4. duration of ultrasound scanning [ Time Frame: 30 minutes ]
    duration of ultrasound scanning

  5. duration of epidural procedure [ Time Frame: 30 minutes ]
    duration of epidural procedure

  6. complications during epidural insertion [ Time Frame: 30 minutes ]
    complications during epidural insertion

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

Inclusion Criteria:

  • Age > 18 years old.
  • Elective major abdominal or thoracic surgery requiring thoracic epidural anesthesia/analgesia.
  • Consent to participate and signed consent form.

Exclusion Criteria:

  • Contraindication to epidural anesthesia.
  • Marked spinal deformities or a history of spinal instrumentation
  • Emergency surgery.
  • Inability to communicate in English.
  • BMI>35 kgm-2

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): NCT01449214

Canada, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Principal Investigator: Cristian Arzola, MD Mount Sinai Hospital, New York

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01449214     History of Changes
Other Study ID Numbers: 11-03
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Thoracic epidural
Epidural anesthesia
Thoracic spine