Ultrasound-Guided Technique for Thoracic Epidural Insertion

Study Overview
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Brief Summary
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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
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• 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

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

Conditions
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Pain

Intervention / Treatment
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* Procedure: Ultrasound
* Procedure: Landmarking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br>Use of ultrasound to identify interlaminar spaces for needle insertion. Intervention/Procedure: ultrasound-guided technique. | Procedure: Ultrasound<br>* Ultrasound-guided technique<br>|
| Active Comparator: Landmarking<br>Use of manual palpation to identify anatomic landmarks for needle insertion. Procedure/Intervention: landmark-guided technique. | Procedure: Landmarking<br>* Landmark-guided technique<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic epidural, Epidural anesthesia, Ultrasound, Palpation, Thoracic spine