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Ultrasound-Guided Technique for Thoracic Epidural Insertion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01449214
First Posted: October 10, 2011
Last Update Posted: May 2, 2016
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):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
  Purpose
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 Intervention
Pain Procedure: Ultrasound Procedure: Landmarking

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • 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:
  • Bony contacts [ Time Frame: 30 minutes ]
    number of bony contacts during the needle insertion

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

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

  • duration of ultrasound scanning [ Time Frame: 30 minutes ]
    duration of ultrasound scanning

  • duration of epidural procedure [ Time Frame: 30 minutes ]
    duration of epidural procedure

  • complications during epidural insertion [ Time Frame: 30 minutes ]
    complications during epidural insertion


Enrollment: 60
Study Start Date: October 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  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
Criteria

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
  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): NCT01449214


Locations
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
Investigators
Principal Investigator: Cristian Arzola, MD Mount Sinai Hospital, New York
  More Information

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01449214     History of Changes
Other Study ID Numbers: 11-03
First Submitted: October 6, 2011
First Posted: October 10, 2011
Last Update Posted: May 2, 2016
Last Verified: April 2016

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