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Completed

NCT Number: NCT01449214

Ultrasound-Guided Technique for Thoracic Epidural Insertion

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Procedure

Ultrasound-guided technique

Landmarking

Procedure

Landmark-guided technique

Primary outcomes

  1. 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

  1. Bony contacts

    Time frame: 30 minutes

    number of bony contacts during the needle insertion

  2. New insertion point

    Time frame: 30 minutes

    need to re-insert the epidural needle in the same interlaminar space, but using different insertion point

  3. Number of insertions

    Time frame: 30 minutes

    number of different interlaminar space insertions

  4. duration of ultrasound scanning

    Time frame: 30 minutes

    duration of ultrasound scanning

  5. duration of epidural procedure

    Time frame: 30 minutes

    duration of epidural procedure

  6. complications during epidural insertion

    Time frame: 30 minutes

    complications during epidural insertion

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2011
Registry last updated
May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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