Ultrasound-Guided Technique for Thoracic Epidural Insertion

Ultrasound-Guided Technique for Thoracic Epidural Insertion: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: 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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network - Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle redirections	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)	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bony contacts	number of bony contacts during the needle insertion	30 minutes
New insertion point	need to re-insert the epidural needle in the same interlaminar space, but using different insertion point	30 minutes
Number of insertions	number of different interlaminar space insertions	30 minutes
duration of ultrasound scanning	duration of ultrasound scanning	30 minutes
duration of epidural procedure	duration of epidural procedure	30 minutes
complications during epidural insertion	complications during epidural insertion	30 minutes

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Cristian Arzola, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 7, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Ultrasound; Epidural anesthesia; Thoracic epidural; Thoracic spine; Palpation
• Other Study ID Numbers: 11-03