Ultrasound-Guided Technique for Thoracic Epidural Insertion

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01449214
First received: October 6, 2011
Last updated: January 29, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Technique for Thoracic Epidural Insertion: A Randomized Controlled Trial

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

Primary Outcome Measures:
  • Needle redirections [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    number of bony contacts during the needle insertion

  • New insertion point [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    need to re-insert the epidural needle in the same interlaminar space, but using different insertion point

  • Number of insertions [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    number of different interlaminar space insertions

  • duration of ultrasound scanning [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    duration of ultrasound scanning

  • duration of epidural procedure [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    duration of epidural procedure

  • complications during epidural insertion [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    complications during epidural insertion


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449214

Contacts
Contact: Cristian Arzola, MD 416-586-4800 ext 5270 carzola@mtsinai.on.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G1X5
Contact: Cristian Arzola, MD    416-586-4800 ext 5270    carzola@mtsinai.on.ca   
Principal Investigator: Cristian Arzola, MD         
Sub-Investigator: Mrinalini Balki, MD         
Sub-Investigator: Shireen Mahmoud, MD         
Sub-Investigator: Zeev Friedman, MD         
University Health Network - Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Rita Katznelson, MD    416-340-4800 ext 2840    rita.katznelson@uhn.ca   
Principal Investigator: Rita Katznelson, MD         
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Cristian Arzola, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01449214     History of Changes
Other Study ID Numbers: 11-03
Study First Received: October 6, 2011
Last Updated: January 29, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 22, 2014