Ultrasound-Guided Technique for Thoracic Epidural Insertion

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449214
• Other study ID #: 11-03
• Status: Completed
• Phase: N/A
• First received: October 6, 2011
• Last updated: April 29, 2016
• Start date: October 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Ultrasound
Ultrasound-guided technique
• Landmarking
Landmark-guided technique

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Bony contacts	number of bony contacts during the needle insertion	30 minutes	No
Secondary	New insertion point	need to re-insert the epidural needle in the same interlaminar space, but using different insertion point	30 minutes	No
Secondary	Number of insertions	number of different interlaminar space insertions	30 minutes	No
Secondary	duration of ultrasound scanning	duration of ultrasound scanning	30 minutes	No
Secondary	duration of epidural procedure	duration of epidural procedure	30 minutes	No
Secondary	complications during epidural insertion	complications during epidural insertion	30 minutes	No