Ultrasound-Guided Technique for Thoracic Epidural Insertion

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: Ultrasound; Procedure: Landmarking

• Registration Number: NCT01449214
• Lead Sponsor: 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

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound	Use of ultrasound to identify interlaminar spaces for needle insertion. Intervention/Procedure: ultrasound-guided technique.
Landmarking	Landmarking	Use of manual palpation to identify anatomic landmarks for needle insertion. Procedure/Intervention: landmark-guided technique.

Primary Outcome Measures

Name	Time	Method
Needle redirections	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

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

Trial Locations

Locations (2)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada