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Clinical Trials/NCT01449214
NCT01449214
Completed
Not Applicable

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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital2 sites in 1 country60 target enrollmentOctober 2011
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Enrollment
60
Locations
2
Primary Endpoint
Needle redirections
Status
Completed
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Needle redirections

Time Frame: 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 Outcomes

  • duration of ultrasound scanning(30 minutes)
  • Bony contacts(30 minutes)
  • New insertion point(30 minutes)
  • Number of insertions(30 minutes)
  • duration of epidural procedure(30 minutes)
  • complications during epidural insertion(30 minutes)

Study Sites (2)

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